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Ebner DW, Johnson HA, Estes C, Johnson WK, Khan RS, Thompson G, Kong J, Camardo M, Dore M, Vahdat V, Fendrick AM, Limburg PJ, Kisiel JB. Multi-target stool DNA and the Fecal Immunochemical Test: A Systematic Review and Meta-analysis on Test Performances. Am J Prev Med 2025:107654. [PMID: 40379061 DOI: 10.1016/j.amepre.2025.107654] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2025] [Revised: 04/30/2025] [Accepted: 05/07/2025] [Indexed: 05/19/2025]
Abstract
INTRODUCTION Colorectal cancer (CRC) remains a leading cause of cancer death in the United States. Since the latest USPSTF update, additional studies examining the performance of the multi-target stool DNA (mt-sDNA) and the fecal immunochemical test (FIT) have been published. This analysis builds upon the USPSTF analysis by including recent studies on test performance. METHODS PubMed and Embase were searched for manuscripts published between December 4, 2019, and July 9, 2024, using colonoscopy as the reference standard. Double-blinded reviewers screened articles. Primary outcomes were test sensitivity and specificity for CRC, advanced neoplasia (AN), advanced precancerous lesions (APLs), and non-advanced precancerous lesions (NAPLs). RESULTS Of 4,320 citations screened, 41 new studies were identified. After combining with 14 studies from the previous USPSTF evidence review, 55 studies were analyzed. Forty-one studies reported the performance of FIT alone, ten of mt-sDNA alone, and four reported FIT and mt-sDNA. Of 14 studies evaluating mt-sDNA, two considered the next-generation mt-sDNA test's CRC sensitivity was 93.6% (95% CI:89.0-97.1) for next-generation mt-sDNA and 71.6% (95% CI:64.3-77.9) for FIT. Specificity was 91.6% (95% CI:89.2-93.7) for next-generation mt-sDNA and 96.3% (95% CI:95.4-97.0) for FIT. APL sensitivity was 22.2% (95% CI:20.6-24.0) for FIT and 45.6% (95% CI:40.8-50.4) for next-generation mt-sDNA. DISCUSSION This meta-analysis revealed that mt-sDNA has high sensitivity for detecting CRC and is more than twice as sensitive than FIT for detecting APL. The lifetime benefit and effectiveness of these tests should be further analyzed.
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Affiliation(s)
- Derek W Ebner
- Mayo Clinic, Division of Gastroenterology and Hepatology, Rochester, MN, USA.
| | | | - Chris Estes
- Exact Sciences Corporation, Madison, WI, USA
| | | | | | | | - Joyce Kong
- Exact Sciences Corporation, Madison, WI, USA
| | | | - Michael Dore
- Department of Medicine, Duke University, Durham, NC, USA
| | | | - A Mark Fendrick
- Division of General Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA
| | | | - John B Kisiel
- Mayo Clinic, Division of Gastroenterology and Hepatology, Rochester, MN, USA
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Zeng F, Chen S, Zhu X, Chen J, Lan M, Chen R, Zhang D, Chen C, Huang S, Li D, Zhang X, Bai F. Analysis of the effect of fecal SDC2, ADHFE1 and PPP2R5C gene methylation test for screening colorectal cancer in the Otog Front Banner. BMC Gastroenterol 2025; 25:324. [PMID: 40307680 PMCID: PMC12042555 DOI: 10.1186/s12876-025-03737-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/17/2024] [Accepted: 02/26/2025] [Indexed: 05/02/2025] Open
Abstract
OBJECTIVE The incidence of colorectal cancer (CRC) is gradually increasing, making the prevention and early detection of CRC a global priority. The purpose of this study is to evaluate the effect of fecal SDC2, ADHFE1, and PPP2R5C gene methylation on the screening of early CRC in the Otog Front Banner. METHODS This is a retrospective study that collected and analyzed data from the early colorectal cancer screening program conducted in five community health centers in the Otog Front Banner, from January 2023 to October 2023. The study collected stool samples from subjects meeting the inclusion and exclusion criteria, extracted genomic DNA from the feces, and modified it with sulfite. Methylation-specific polymerase chain reaction (MSP) was then used to detect the methylation status of the SDC2, PPP2R5C, and ADHFE1 genes, completing the early screening for colorectalcancer. Individuals with positive screening outcomes were advised to undergo a colonoscopy, and ultimately, all participants completed the questionnaire on high-risk factors for colorectal cancer . The chi-square test was utilized to analyze the positive rates of fecal SDC2, ADHFE1, and PPP2R5C gene methylation screenings, colonoscopy compliance, the positive predictive value of intestinal lesions, and to assess the risk factors associated with cancer. RESULTS A total of 9,135 effective screeners were included in this study, and 636 of them tested positive during the initial screening, yielding a positive rate of 6.9%. The positive predictive value was 50.9% for all intestinal lesions, 1.4% for colorectal cancer , and 9.7% for advanced adenoma. CONCLUSION Fecal SDC2, ADHFE1, and PPP2R5C gene methylation detection methods can serve as primary screening tools, supplemented by colonoscopy, to effectively detect colorectal cancer and precancerous lesions. This strategy may prove to be an effective approach for conducting large-scale colorectal cancer screening in average-risk populations.
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Affiliation(s)
- Fan Zeng
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Shiiu Chen
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Xuli Zhu
- Otog Front Banner Peoples Hospital, Inner Mongolia Autonomous Region, China, 016200, Ordos, 016200, China
| | - Jinrun Chen
- Otog Front Banner Peoples Hospital, Inner Mongolia Autonomous Region, China, 016200, Ordos, 016200, China
| | - Maochong Lan
- Graduate School, Jiujiang College, Jiujiang, 332001, China
| | - Runxiang Chen
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Daya Zhang
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Chen Chen
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Shimei Huang
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Da Li
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Xiaodong Zhang
- The Second School of Clinical Medicine, Hainan Medical University, Haikou, 571199, China
| | - Feihu Bai
- Department of Gastroenterology, The Second Affiliated Hospital of Hainan Medical University, Yehai Avenue, #368, Longhua District, Haikou, Hainan Province, 570216, China.
- The Gastroenterology Clinical Medical Center of Hainan Province, Haikou, 570216, China.
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Wang C, Shaukat A. Optimal Approach to Colorectal Cancer Screening. Gastroenterol Hepatol (N Y) 2025; 21:163-171. [PMID: 40115656 PMCID: PMC11920019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/23/2025]
Abstract
Rates of colorectal cancer (CRC) screening in the United States continue to fall short of guideline-recommended benchmarks. Challenges to increasing CRC screening include racial disparities, barriers at multiple levels of the health care system, and inadequate completion of 2-step screening. With new options for CRC screening and employment of programmatic strategies for screening by physicians, patients will have more opportunities to initiate and complete testing, which can ultimately improve CRC detection and prevention. This article highlights the current state of and optimal approach to CRC screening.
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Affiliation(s)
- Christina Wang
- Division of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Aasma Shaukat
- Division of Gastroenterology, Department of Medicine, New York University Grossman School of Medicine and the VA New York Harbor Health Care, New York, New York
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Lee HJ, Lee K, Kim BC, Jun JK, Choi KS, Suh M. Effectiveness of the Korean National Cancer Screening Program in Reducing Colorectal Cancer Mortality. Cancers (Basel) 2024; 16:4278. [PMID: 39766178 PMCID: PMC11674503 DOI: 10.3390/cancers16244278] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2024] [Revised: 12/20/2024] [Accepted: 12/22/2024] [Indexed: 01/11/2025] Open
Abstract
BACKGROUND Whether colorectal cancer (CRC) screening with a fecal immunochemical test (FIT) reduces mortality remains unclear. In South Korea, CRC screening with a FIT for individuals aged ≥ 50 years has been part of the Korean National Cancer Screening Program (KNCSP) since 2004. The aim of this study was to evaluate the effectiveness of the KNCSP in reducing CRC-specific mortality. METHODS We conducted a nested case-control study using cohort-based data derived from the KNCSP database. The cohort included 5,944,540 colorectal cancer-free individuals aged ≥ 50 years as of 2004. Individuals who died after CRC diagnosis were defined as cases (n = 29,992) and their sociodemographic characteristics were matched to those of the selected controls. The effects of screening exposure, frequency, and time interval on CRC-specific mortality were analyzed according to age group. Conditional logistic regression analysis was performed. RESULTS Compared with individuals who had never been screened, those who had ever been screened showed an OR of 0.74 (95% CI, 0.71-0.76) for CRC-specific mortality. CRC-specific mortality decreased as the number of screenings increased. Similar results were observed for those aged 50-79 years; however, the results for those aged 75-79 years were not statistically significant. Moreover, those aged ≥ 80 years had the opposite results. CONCLUSIONS CRC mass screening using FIT is effective for individuals aged 50-74 years; therefore, this study suggests that countries considering introducing national CRC screening implement FIT for those within this age range.
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Affiliation(s)
- Hyeon Ji Lee
- National Cancer Control Institute, National Cancer Center, Goyang 10408, Republic of Korea; (H.J.L.)
| | - Kyeongmin Lee
- Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang 10408, Republic of Korea
| | - Byung Chang Kim
- Center for Colorectal Cancer, Center for Cancer Prevention and Detection, National Cancer Center, Goyang 10408, Republic of Korea
| | - Jae Kwan Jun
- National Cancer Control Institute, National Cancer Center, Goyang 10408, Republic of Korea; (H.J.L.)
- Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang 10408, Republic of Korea
| | - Kui Son Choi
- National Cancer Control Institute, National Cancer Center, Goyang 10408, Republic of Korea; (H.J.L.)
- Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang 10408, Republic of Korea
| | - Mina Suh
- National Cancer Control Institute, National Cancer Center, Goyang 10408, Republic of Korea; (H.J.L.)
- Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang 10408, Republic of Korea
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Reuland DS, O’Leary MC, Crockett SD, Farr DE, Ferrari RM, Malo TL, Moore AA, Randolph CM, Ratner S, Stradtman LR, Stylianou C, Su K, Tan X, Tang V, Wheeler SB, Brenner AT. Centralized Colorectal Cancer Screening Outreach in Federally Qualified Health Centers: A Randomized Clinical Trial. JAMA Netw Open 2024; 7:e2446693. [PMID: 39585696 PMCID: PMC11589799 DOI: 10.1001/jamanetworkopen.2024.46693] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2024] [Accepted: 09/23/2024] [Indexed: 11/26/2024] Open
Abstract
Importance Colorectal cancer (CRC) screening is effective but remains underused in federally qualified health centers (FQHCs). Objective To assess the effectiveness of a centralized CRC screening outreach intervention involving mailed fecal immunochemical testing (FIT) outreach and patient navigation to colonoscopy after abnormal results of FIT. Design, Setting, and Participants A pragmatic randomized clinical trial was conducted, using intention-to-treat analysis. Participants were enrolled from July 6, 2020, to September 17, 2021, and analyses were performed from July 6, 2023, to January 31, 2024. The study was conducted at independent FQHCs comprising 12 clinical delivery sites in North Carolina. The outreach intervention was centralized at an academic cancer center. Active individuals aged 50 to 75 years at average risk for CRC and not current with screening per US Preventive Services Task Force recommendations were included. Intervention In addition to usual care, intervention participants received mailed screening outreach materials including an introductory letter, FIT kit packet with instructions and return postage, and 2 reminder letters if needed. Intervention participants with positive results of mailed FIT were offered navigation to facilitate follow-up colonoscopy completion. Control participants received usual care alone. Main Outcomes and Measures The primary outcome was completion of a US Preventive Services Task Force-recommended CRC screening test within 6 months determined by electronic health record review. Secondary outcomes were colonoscopy completion within 6 months after positive FIT results and detection of advanced colorectal neoplasia, defined as advanced adenoma or CRC. Results A total of 4002 participants were included (mean [SD] age, 59.6 [6.8] years; 2256 [56.4%] female; 364 (9.1%) Hispanic; 1082 [27.0%] non-Hispanic Black; 2288 [57.2%] non-Hispanic White; 1198 [29.9%] commercially insured; 617 [15.4%] Medicaid; 1227 [30.7%] Medicare; and 960 [24.0%] uninsured), with 2001 randomized to each group. Compared with controls, intervention participants were more likely to complete screening within 6 months of randomization (30.0% vs 9.7%; difference, 20.29 percentage points; 95% CI, 17.85-22.73 percentage points). The intervention was effective in all insurance types. In the intervention arm, 33 of 48 participants with positive FIT results (68.8%) completed follow-up colonoscopy within 6 months compared with 8 of 18 participants (44.4%) in the control arm (difference, 24.3 percentage points; 95% CI, -2.13 to 50.74 percentage points). Advanced colorectal neoplasia was detected in 29 intervention participants (1.4%) and 15 control participants (0.7%) (difference, 0.68 percentage points; 95% CI, 0.05-1.35 percentage points). Conclusions and Relevance In this randomized clinical trial of centralized screening outreach intervention in diverse patients served by independent FQHCs, CRC screening completion and advanced colorectal neoplasia detection were substantially increased. Future studies should examine the cost and scalability of this intervention in this context. Trial Registration ClinicalTrials.gov Identifier: NCT04406714.
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Affiliation(s)
- Daniel S. Reuland
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Medicine, Division of General Medicine and Clinical Epidemiology, University of North Carolina School of Medicine, Chapel Hill
| | - Meghan C. O’Leary
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina School of Medicine, Chapel Hill
| | - Seth D. Crockett
- Division of Gastroenterology and Hepatology, Oregon Health & Science University, Portland
| | - Deeonna E. Farr
- Department of Health Education and Promotion, College of Health and Human Performance, East Carolina University, Greenville, North Carolina
| | - Renée M. Ferrari
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Maternal and Child Health, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill
| | - Teri L. Malo
- Patient Support Pillar, American Cancer Society, Kennesaw, Georgia
| | - Alexis A. Moore
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
| | - Connor M. Randolph
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Health Behavior, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill
| | - Shana Ratner
- Department of Medicine, Division of General Medicine and Clinical Epidemiology, University of North Carolina School of Medicine, Chapel Hill
| | - Lindsay R. Stradtman
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
| | - Christina Stylianou
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
| | - Kevin Su
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Biostatistics, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill
| | - Xianming Tan
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Biostatistics, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill
| | - Van Tang
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
| | - Stephanie B. Wheeler
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina School of Medicine, Chapel Hill
| | - Alison T. Brenner
- Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill
- Department of Medicine, Division of General Medicine and Clinical Epidemiology, University of North Carolina School of Medicine, Chapel Hill
- Center for Health Promotion and Disease Prevention, The University of North Carolina at Chapel Hill
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Gerrard AD, Garau R, Xu W, Maeda Y, Dunlop MG, Theodoratou E, Din FVN. Repeat Faecal Immunochemical Testing for Colorectal Cancer Detection in Symptomatic and Screening Patients: A Systematic Review and Meta-Analysis. Cancers (Basel) 2024; 16:3199. [PMID: 39335170 PMCID: PMC11429846 DOI: 10.3390/cancers16183199] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2024] [Revised: 09/03/2024] [Accepted: 09/10/2024] [Indexed: 09/30/2024] Open
Abstract
BACKGROUND Faecal immunochemical testing (FIT) is widely used in bowel screening programmes and assessing symptomatic patients for suspected colorectal cancer (CRC). The evidence for single test performance of FIT in both settings is considerable; however, the use of a repeat test to increase sensitivity remains uncertain. We aimed to review what increase in test positivity would be generated by additional FITs, whether a repeated FIT detects previously missed CRC and advanced colorectal neoplasia (ACRN), and to estimate the sensitivity of double-FIT strategies to diagnose CRC and ACRN. METHODS A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) was performed using key search terms. Studies reporting the use of more than one FIT in the same screening round or planned assessment of a single symptomatic patient episode were included. Studies were categorised by the reported study population into asymptomatic, mixed (cohorts of combined asymptomatic, symptomatic, or high-risk surveillance), or symptomatic cohorts. RESULTS A total of 68 studies were included for analysis (39 asymptomatic, 21 mixed, 7 symptomatic, and 1 study with discrete asymptomatic and symptomatic data). At a threshold of 10 µg Hb/g, the two-test positivity ranged between 8.1 and 34.5%, with an increase from the second test of 3-9.2 percentage points. Four out of five studies comparing one versus two tests for diagnosing CRC at 10 µg Hb/g identified additional cases with the second test, with a minimum of 50% reduction in missed CRC. At a threshold of 20 µg Hb/g, the second test increased the positivity by 1.3-6.7 percentage points, with a two-test positivity of between 5.1 and 25.0%. Using a threshold of 20 µg Hb/g, five out of seven studies had a 25% reduction in missed CRC. A meta-analysis estimated the double-FIT sensitivity at 10 µg Hb/g for CRC in mixed-risk and symptomatic cohorts to be 94% and 98%, respectively. CONCLUSIONS Repeated use of FIT helps to diagnose more cases of CRC with a moderate increase in positivity. A double-FIT strategy at 10 µg Hb/g in mixed and symptomatic cohorts has a very high sensitivity for CRC.
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Affiliation(s)
- Adam D. Gerrard
- Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh EH4 2XR, UK; (A.D.G.); (E.T.)
- Department of Colorectal Surgery, Western General Hospital, Edinburgh EH4 2XU, UK
| | - Roberta Garau
- Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh EH4 2XR, UK; (A.D.G.); (E.T.)
- Department of Colorectal Surgery, Western General Hospital, Edinburgh EH4 2XU, UK
| | - Wei Xu
- Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh EH4 2XR, UK; (A.D.G.); (E.T.)
- Centre for Global Health, Usher Institute, The University of Edinburgh, Edinburgh EH4 2XR, UK
| | - Yasuko Maeda
- School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow G12 8QQ, UK
- Department of Surgery, Queen Elizabeth University Hospital, Glasgow G51 4TF, UK
| | - Malcolm G. Dunlop
- Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh EH4 2XR, UK; (A.D.G.); (E.T.)
- UK Colon Cancer Genetics Group, Medical Research Council Human Genetics Unit, Medical Research Council Institute of Genetics & Cancer, Western General Hospital, The University of Edinburgh, Edinburgh EH4 2XU, UK
| | - Evropi Theodoratou
- Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh EH4 2XR, UK; (A.D.G.); (E.T.)
- Centre for Global Health, Usher Institute, The University of Edinburgh, Edinburgh EH4 2XR, UK
| | - Farhat V. N. Din
- Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh EH4 2XR, UK; (A.D.G.); (E.T.)
- Department of Colorectal Surgery, Western General Hospital, Edinburgh EH4 2XU, UK
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Zarandi-Nowroozi M, Taghiakbari M, Barkun A, Pohl H, Nauche B, Chagnon M, von Renteln D. Effect of fecal immunochemical test cut-off levels on adenoma detection rate: a systematic review and meta-analysis. Scand J Gastroenterol 2024; 59:882-892. [PMID: 38775234 DOI: 10.1080/00365521.2024.2356649] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/04/2023] [Revised: 04/16/2024] [Accepted: 04/23/2024] [Indexed: 07/30/2024]
Abstract
BACKGROUND Adenoma detection rate (ADR) is higher after a positive fecal immunochemical test (FIT) compared to direct screening colonoscopy. OBJECTIVE This meta-analysis evaluated how ADR, the rates of advanced adenoma detection (AADR), colorectal cancer detection (CDR), and sessile serrated lesion detection (SSLDR) are affected by different FIT positivity thresholds. METHODS We searched MEDLINE, EMBASE, CINAHL, and EBM Reviews databases for studies reporting ADR, AADR, CDR, and SSLDR according to different FIT cut-off values in asymptomatic average-risk individuals aged 50-74 years old. Data were stratified according to sex, age, time to colonoscopy, publication year, continent, and FIT kit type. Study quality, heterogeneity, and publication bias were assessed. RESULTS Overall, 4280 articles were retrieved and fifty-eight studies were included (277,661 FIT-positive colonoscopies; mean cecal intubation 96.3%; mean age 60.8 years; male 52.1%). Mean ADR was 56.1% (95% CI 53.4 - 58.7%), while mean AADR, CDR, and SSLDR were 27.2% (95% CI 24.4 - 30.1%), 5.3% (95% CI 4.7 - 6.0%), and 3.0% (95% CI 1.7 - 4.6%), respectively. For each 20 μg Hb/g increase in FIT cut-off level, ADR increased by 1.54% (95% CI 0.52 - 2.56%, p < 0.01), AADR by 3.90% (95% CI 2.76 - 5.05%, p < 0.01) and CDR by 1.46% (95% CI 0.66 - 2.24%, p < 0.01). Many detection rates were greater amongst males and Europeans. CONCLUSIONS ADRs in FIT-positive colonoscopies are influenced by the adopted FIT positivity threshold, and identified targets, importantly, proved to be higher than most current societal recommendations.
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Affiliation(s)
- Melissa Zarandi-Nowroozi
- Division of Gastroenterology, University of Montreal Hospital Center (CHUM), Montreal, Quebec, Canada
| | - Mahsa Taghiakbari
- Department of Gastroenterology, University of Montreal Hospital Research Center (CRCHUM), Montreal, Quebec, Canada
| | - Alan Barkun
- Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada
| | - Heiko Pohl
- Dartmouth Geisel School of Medicine, Hanover, NH, USA
- Section of Gastroenterology and Hepatology, VA White River Junction, White River Junction, VT, USA
| | - Bénédicte Nauche
- Department of Library, University of Montreal Hospital Center (CHUM), Montreal, Quebec, Canada
| | - Miguel Chagnon
- Department of Mathematics and Statistics, University of Montreal, Montreal, Quebec, Canada
| | - Daniel von Renteln
- Division of Gastroenterology, University of Montreal Hospital Center (CHUM), Montreal, Quebec, Canada
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8
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Liao Z, Guo JT, Yang F, Wang SP, Sun SY. Screening of colorectal cancer: Methods and strategies. World J Clin Oncol 2024; 15:799-805. [PMID: 39071460 PMCID: PMC11271723 DOI: 10.5306/wjco.v15.i7.799] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/18/2024] [Revised: 05/14/2024] [Accepted: 05/27/2024] [Indexed: 07/16/2024] Open
Abstract
Colorectal cancer (CRC) has high incidence and mortality rates, and the emergence and application of CRC screening have helped us effectively control the occurrence and development of CRC. Currently, common international screening methods include tests based on feces and blood, and examination methods that allow for visualization, such as sigmoidoscopy and colonoscopy. Some methods have been widely used, whereas others such as multi-target stool RNA test are still being explored and developed, and are expected to become front-line screening methods for CRC in the future. The choice of screening method is affected by external conditions and the patients' situation, and the clinician must choose an appropriate strategy according to the actual situation and the patient's wishes. This article introduces various CRC screening methods and analyzes the factors relevant to the screening strategy.
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Affiliation(s)
- Zhen Liao
- Department of Gastroenterology, Engineering Research Center of Ministry of Education for Minimally Invasive Gastrointestinal Endoscopic Techniques, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
| | - Jin-Tao Guo
- Department of Gastroenterology, Engineering Research Center of Ministry of Education for Minimally Invasive Gastrointestinal Endoscopic Techniques, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
| | - Fan Yang
- Department of Gastroenterology, Engineering Research Center of Ministry of Education for Minimally Invasive Gastrointestinal Endoscopic Techniques, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
| | - Shu-Peng Wang
- Department of Gastroenterology, Engineering Research Center of Ministry of Education for Minimally Invasive Gastrointestinal Endoscopic Techniques, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
| | - Si-Yu Sun
- Department of Gastroenterology, Engineering Research Center of Ministry of Education for Minimally Invasive Gastrointestinal Endoscopic Techniques, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
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Tonini V, Zanni M. Why is early detection of colon cancer still not possible in 2023? World J Gastroenterol 2024; 30:211-224. [PMID: 38314134 PMCID: PMC10835528 DOI: 10.3748/wjg.v30.i3.211] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2023] [Revised: 10/30/2023] [Accepted: 12/14/2023] [Indexed: 01/18/2024] Open
Abstract
Colorectal cancer (CRC) screening is a fundamental tool in the prevention and early detection of one of the most prevalent and lethal cancers. Over the years, screening, particularly in those settings where it is well organized, has succeeded in reducing the incidence of colon and rectal cancer and improving the prognosis related to them. Despite considerable advancements in screening technologies and strategies, the effectiveness of CRC screening programs remains less than optimal. This paper examined the multifaceted reasons behind the persistent lack of effectiveness in CRC screening initiatives. Through a critical analysis of current methodologies, technological limitations, patient-related factors, and systemic challenges, we elucidated the complex interplay that hampers the successful reduction of CRC morbidity and mortality rates. While acknowledging the advancements that have improved aspects of screening, we emphasized the necessity of addressing the identified barriers comprehensively. This study aimed to raise awareness of how important CRC screening is in reducing costs for this disease. Screening and early diagnosis are not only important in improving the prognosis of patients with CRC but can lead to an important reduction in the cost of treating a disease that is often diagnosed at an advanced stage. Spending more sooner can mean saving money later.
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Affiliation(s)
- Valeria Tonini
- Department of Medical and Surgical Sciences, University of Bologna, Bologna 40138, Italy
| | - Manuel Zanni
- Department of Medical and Surgical Sciences, University of Bologna, Bologna 40138, Italy
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10
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Maqbool M, Khan A, Shahzad A, Sarfraz Z, Sarfraz A, Aftab H, Jaan A. Predictive biomarkers for colorectal cancer: a state-of-the-art systematic review. Biomarkers 2023; 28:562-598. [PMID: 37585692 DOI: 10.1080/1354750x.2023.2247185] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/06/2023] [Accepted: 08/06/2023] [Indexed: 08/18/2023]
Abstract
INTRODUCTION Colorectal cancer (CRC) poses a substantial health burden, with early detection paramount for improved prognosis. This study aims to evaluate potential CRC biomarkers and detection techniques. MATERIALS AND METHODS This systematic review, reported in adherence to PRISMA Statement 2020 guidelines, collates the latest research on potential biomarkers and detection/prognosis methods for CRC, spanning the last decade. RESULTS Out of the 38 included studies, diverse biomarkers and detection methods emerged, with DNA methylation markers like SFRP2 and SDC2, microRNAs including miR-1290, miR-506, and miR-4316, and serum and plasma markers such as NTS levels and U2 snRNA fragments standing out. Methylated cfDNA and m5C methylation alteration in immune cells of the blood, along with circular RNA, showed promise as diagnostic markers. Meanwhile, techniques involving extracellular vesicles and lateral flow immunoassays exhibited potential for swift and effective CRC screening. DISCUSSION Our state-of-the-art review identifies potential biomarkers, including SFRP2, SDC2, miR-1290, miR-506, miR-4316, and U2 snRNA fragments, with significant potential in enhancing CRC detection. However, comprehensive validation studies and a rigorous evaluation of clinical utility and cost-effectiveness remain necessary before integration into routine clinical practice. CONCLUSION The findings emphasize the need for continued research into biomarkers and detection methods to improve patient outcomes.
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Affiliation(s)
- Moeez Maqbool
- Sheikh Zayed Medical College, Rahim Yar Khan, Pakistan
| | - Aden Khan
- Fatima Jinnah Medical University, Lahore, Pakistan
| | | | | | | | - Hinna Aftab
- CMH Lahore Medical and Dental College, Lahore, Pakistan
| | - Ali Jaan
- Rochester General Hospital, Rochester, NY, USA
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11
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Li B, Liu S, Gao Y, Zheng L, Lu Y. Combined detection of SDC2/ADHFE1/PPP2R5C methylation in stool DNA for colorectal cancer screening. J Cancer Res Clin Oncol 2023; 149:10241-10253. [PMID: 37270460 DOI: 10.1007/s00432-023-04943-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/04/2023] [Accepted: 05/26/2023] [Indexed: 06/05/2023]
Abstract
BACKGROUND Colorectal cancer (CRC) is a disease of global concern, and its increasing incidence suggests the need for early and accurate diagnosis. The aim of this study was to investigate the value of combined detection of SDC2, ADHFE1 and PPP2R5C gene methylation in stool samples for early CRC screening. METHODS Stool samples from patients with CRC (n = 105), advanced adenoma (AA) (n = 54), non-advanced adenoma (NA) (n = 57), hyperplastic or other polyps (HOP) (n = 47) or no evidence of disease (NED) (n = 100) were collected from September 2021 to September 2022. The methylation levels of SDC2, ADHFE1 and PPP2R5C were quantified by quantitative methylation-specific polymerase chain reaction (qMSP), and faecal immunochemical testing (FIT) was performed. The diagnostic value was assessed using reporter operating characteristic (ROC) curve analysis. RESULTS The sensitivity of combined detection of SDC2/ADHFE1/PPP2R5C methylation in predicting CRC (0-IV) was 84.8%, the specificity was 98.0%, and the AUC was 0.930 (95% CI 0.889-0.970). Compared to FIT and serum tumour biomarkers, it showed better diagnostic performance for different stages of CRC. CONCLUSION The results of this study verified that the methylation levels of SDC2, ADHFE1 and PPP2R5C in stool DNA were significantly increased in CRC patients. Combined detection of SDC2/ADHFE1/PPP2R5C methylation is a potential non-invasive diagnostic method for CRC and precancerous lesion screening. CLINICAL TRIAL REGISTRATION Chinese Clinical Trials Registry, ChiCTR2100046662, registered on 26 May 2021, prospective registration.
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Affiliation(s)
- Ben Li
- Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China
| | - Shanglong Liu
- Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China
| | - Yuan Gao
- Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China
| | - Longbo Zheng
- Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China
| | - Yun Lu
- Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China.
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12
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Chandrasekar D, Guerrier C, Alisson-Silva F, Dhar C, Caval T, Schwarz F, Hommes DW. Warning Signs From the Crypt: Aberrant Protein Glycosylation Marks Opportunities for Early Colorectal Cancer Detection. Clin Transl Gastroenterol 2023; 14:e00592. [PMID: 37141103 PMCID: PMC10371329 DOI: 10.14309/ctg.0000000000000592] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/04/2023] [Accepted: 04/18/2023] [Indexed: 05/05/2023] Open
Abstract
Colorectal cancer (CRC) remains a leading cause of cancer-related deaths despite being the most preventable and treatable forms of cancer when caught early through screening. There is an unmet need for novel screening approaches with improved accuracy, less invasiveness, and reduced costs. In recent years, evidence has accumulated around particular biological events that happen during the adenoma-to-carcinoma transition, especially focusing on precancerous immune responses in the colonic crypt. Protein glycosylation plays a central role in driving those responses, and recently, numerous reports have been published on how aberrant protein glycosylation both in colonic tissue and on circulating glycoproteins reflects these precancerous developments. The complex field of glycosylation, which exceeds complexity of proteins by several orders of magnitude, can now be studied primarily because of the availability of new high-throughput technologies such as mass spectrometry and artificial intelligence-powered data processing. This has now opened new avenues for studying novel biomarkers for CRC screening. This review summarizes the early events taking place from the normal colon mucosa toward adenoma and adenocarcinoma formation and associated critical protein glycosylation phenomena, both on the tissue level and in the circulation. These insights will help establish an understanding in the interpretation of novel CRC detection modalities that involve high-throughput glycomics.
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Affiliation(s)
| | | | | | - Chirag Dhar
- InterVenn Biosciences, South San Francisco, California, USA
| | - Tomislav Caval
- InterVenn Biosciences, South San Francisco, California, USA
| | - Flavio Schwarz
- InterVenn Biosciences, South San Francisco, California, USA
| | - Daniel W. Hommes
- InterVenn Biosciences, South San Francisco, California, USA
- Leiden University Medical Center, Leiden, the Netherlands.
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13
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Segura A, Siddique SM. Reducing disparities and achieving health equity in colorectal cancer screening. TECHNIQUES AND INNOVATIONS IN GASTROINTESTINAL ENDOSCOPY 2023; 25:284-296. [PMID: 37808233 PMCID: PMC10554575 DOI: 10.1016/j.tige.2023.02.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/10/2023]
Abstract
Increases in colorectal cancer screening are linked to the declining incidence of the disease over the past three decades. These favorable trends, however, are not observed in marginalized racial and ethnic populations with disproportionately lower rates of screening, higher disease incidence, and increased mortality despite advances in health technology and policy. This review describes the differences in screening uptake and test selection amongst racial and ethnic groups, discusses known obstacles and facilitators that impact screening, and highlights existing frameworks developed to achieve health equity in colorectal cancer screening.
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Affiliation(s)
- Abraham Segura
- Division of Gastroenterology, University of Pennsylvania
| | - Shazia Mehmood Siddique
- Division of Gastroenterology, University of Pennsylvania
- Leonard Davis Institute for Health Economics, University of Pennsylvania
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14
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Edwardson N, Adsul P, Gonzalez Z, Pankratz VS, Parasher G, English K, Mishra S. Sessile serrated lesion detection rates continue to increase: 2008-2020. Endosc Int Open 2023; 11:E107-E116. [PMID: 36712908 PMCID: PMC9879655 DOI: 10.1055/a-1990-0509] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/13/2022] [Accepted: 11/17/2022] [Indexed: 01/28/2023] Open
Abstract
Background and study aims We assessed sessile serrated lesion detection rate (SSLDR) at a large academic medical center from 2008 to 2020 and modeled a local, aspirational target SSLDR. We also assessed SSLDRs among all gastroenterology fellows to better understand the relationship between SSLDRs and total colonoscopies performed. Patients and methods SSL-positive pathology results were flagged from a dataset composed of all screening colonoscopies for average-risk patients from 2008 to 2020. Unadjusted SSLDRs were calculated for individual endoscopists by year. A mixed effects logistic regression was used to estimate the log odds of SSL detection, with one model estimating division-wide predictors of SSL detection and a second model focused exclusively on colonoscopies performed by fellows. Model-adjusted SSLDRs were estimated for all 13 years and across both categories of all endoscopists and fellows only. Results Adjusted SSLDRs showed a consistent improvement in SSLDR from a low of 0.37 % (95 % confidence interval [CI]: 0.10-0.63) in 2008 to a high of 7.94 % (95 % CI: 6.34-9.54) in 2020. Among fellows only, the odds of SSL detection were significantly lower during their first year compared to their second year (OR: 0.80, 95 % CI: 0.66-0.98) but not significantly higher in their third year compared to their second year (OR: 1.09, 95 % CI: 0.85-1.4). Conclusions SSLDR increased steadily and significantly throughout our study period but variance among endoscopists persists. The peak SSLDR from 2020 of 7.94 % should serve as the local aspirational target for this division's attendings and fellows but should be continuously reevaluated.
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Affiliation(s)
- Nicholas Edwardson
- University of New Mexico, School of Public Administration, Albuquerque, New Mexico, United States
| | - Prajakta Adsul
- University of New Mexico, Department of Internal Medicine, Albuquerque, New Mexico, United States
- University of New Mexico, Comprehensive Cancer Center, Cancer Control and Population Sciences, Albuquerque, New Mexico, United States
| | - Zorisadday Gonzalez
- University of New Mexico, Department of Internal Medicine, Albuquerque, New Mexico, United States
| | - V. Shane Pankratz
- University of New Mexico, Department of Internal Medicine, Albuquerque, New Mexico, United States
- University of New Mexico, Comprehensive Cancer Center, Cancer Control and Population Sciences, Albuquerque, New Mexico, United States
| | - Gulshan Parasher
- University of New Mexico, Department of Internal Medicine, Albuquerque, New Mexico, United States
- University of New Mexico, Department of Gastroenterology, Albuquerque, New Mexico, United States
| | - Kevin English
- Albuquerque Area Indian Health Board Inc., Albuquerque Area Southwest Tribal Epidemiology Center, Albuquerque, New Mexico, United States
| | - Shiraz Mishra
- University of New Mexico, Comprehensive Cancer Center, Cancer Control and Population Sciences, Albuquerque, New Mexico, United States
- University of New Mexico, Department of Pediatrics, Albuquerque, New Mexico, United States
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15
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Yaghoobi M, Mehraban Far P, Mbuagbaw L, Yuan Y, Armstrong D, Thabane L, Moayyedi P. Potential Modifiers and Different Cut-offs in Diagnostic Accuracy of Fecal Immunochemical Test in Detecting Advanced Colon Neoplasia: A Diagnostic Test Accuracy Meta-analysis. Middle East J Dig Dis 2022; 14:382-395. [PMID: 37547494 PMCID: PMC10404105 DOI: 10.34172/mejdd.2022.299] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/03/2022] [Accepted: 07/29/2022] [Indexed: 08/08/2023] Open
Abstract
Background: Fecal immunoglobulin test (FIT) has been advocated as the first line of screening for colorectal cancer (CRC) in several jurisdictions. Most studies have focused on CRC as the outcome of interest. Our goal was to quantify the diagnostic accuracy of different thresholds of FIT as compared with colonoscopy for detection of advanced colonic neoplasia and potential modifiers using proper Cochrane methodology. Methods: A comprehensive electronic search was performed for studies on FIT using colonoscopy as the reference standard to detect advanced neoplasia. Cochrane methodology was used to perform a diagnostic test accuracy (DTA) meta-analysis. Diagnostic accuracy of different cut-offs of FIT, including 25, 50, 75, 100, 150, and 200 ng/mL, were calculated separately. Meta-regression analysis was also performed to detect potential a priori modifiers, including age, location of the tumor, and time from FIT to colonoscopy. Results: Twenty-four studies were included with no evidence of publication bias. The sensitivity of FIT did not decrease with lowering the cut-off, although specificity increased in higher cut-offs. Commonly used cut-offs of 50 ng/mL, 75 ng/mL, and 100 ng/mL for FIT provided sensitivity of 39%, 36%, 27% and specificity of 92%, 94%, 96%, respectively. Diagnostic accuracy of FIT did not significantly differ in proximal versus distal lesions or in individuals below or over the age of 50 years. The results remained robust in a meta-regression of the location of the study, time from FIT to colonoscopy, and methodological quality. Conclusion: The sensitivity of FIT might have been overestimated in previous studies focusing on CRC, and it seems to be independent of age, location of neoplasia, or cut-offs, contrary to some previous studies. Lowering the cut-off will reduce the diagnostic odds ratio (DOR) by increasing specificity but without any effect on sensitivity.
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Affiliation(s)
- Mohammad Yaghoobi
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada
- Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Ontario, Canada
- Cochrane GUT, Hamilton, Ontario, Canada
- The Farncombe Family Digestive Health Research Institute, Hamilton, Ontario, Canada
| | - Parsa Mehraban Far
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada
- Division of Medicine, Queen’s University, Kingston, Ontario, Canada
| | - Lawrence Mbuagbaw
- Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Ontario, Canada
- Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada
- Biostatistics Unit/The Research Institute, St Joseph’s Healthcare, Hamilton, Ontario, Canada
| | - Yuhong Yuan
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada
- Cochrane GUT, Hamilton, Ontario, Canada
- The Farncombe Family Digestive Health Research Institute, Hamilton, Ontario, Canada
| | - David Armstrong
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada
- The Farncombe Family Digestive Health Research Institute, Hamilton, Ontario, Canada
| | - Lehana Thabane
- Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Ontario, Canada
- Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada
- Biostatistics Unit/The Research Institute, St Joseph’s Healthcare, Hamilton, Ontario, Canada
- Departments of Anesthesia/Pediatrics; Schools of Nursing/Rehabilitation Sciences, Master University, Hamilton, Ontario, Canada
| | - Paul Moayyedi
- Division of Gastroenterology, McMaster University, Hamilton, Ontario, Canada
- Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Ontario, Canada
- Cochrane GUT, Hamilton, Ontario, Canada
- The Farncombe Family Digestive Health Research Institute, Hamilton, Ontario, Canada
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16
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Bondre MF, Al Qubtan M, Al Harthy SO. Assessing Suitability of a Colorectal Cancer Screening Program in Oman. Cureus 2022; 14:e27011. [PMID: 35874903 PMCID: PMC9298662 DOI: 10.7759/cureus.27011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/19/2022] [Indexed: 11/29/2022] Open
Abstract
Colorectal cancer is among the most common cancers globally and carries a high mortality rate. The incidence of colorectal cancer has been increasing in the Middle East, including in Oman. While many countries have implemented a bowel cancer screening program, Oman has yet to establish one. A standard tool for bowel cancer screening is a fecal immunochemical test where a fecal sample is sent to a laboratory to check for blood content in the feces. In Oman, such fecal test kits are available at the primary health care level, but primary care physicians were unaware of the signs and symptoms or screening methods for colorectal cancer. This review article aims to assess the suitability of a colorectal cancer screening program in Oman using guidelines from the Supporting the Use of Research Evidence (SURE) collaboration.
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17
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Shu T, Wu K, Guo Y, He Q, Song X, Shan J, Wu L, Liu J, Wang Z, Liu L, Sun X. Evaluation of fecal SYPL1 as a diagnostic biomarker in colorectal cancer. Clin Biochem 2022; 103:8-15. [PMID: 35218739 DOI: 10.1016/j.clinbiochem.2022.02.009] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2021] [Revised: 02/06/2022] [Accepted: 02/21/2022] [Indexed: 12/24/2022]
Abstract
BACKGROUND At present, there is still no ideal non-invasive biomarker for colorectal cancer (CRC) screening. Previously, we foundserum synaptophysin like 1 (SYPL1) served as a potential biomarker for CRC diagnosis. However, whether fecal SYPL1 (fSYPL1) are more sensitive and specific for CRC remains unclear. METHODS We analyzed fSYPL1 in controls (n = 70), adenoma patients (n = 80), CRC patients (n = 150) and postoperative CRC patients (n = 25) by ELISA. RESULTS SYPL1 was stable in feces. The fSYPL1 levels were significantly higher in CRC patients than in either controls or adenoma patients (P < 0.0001). ROC curves showed that fSYPL1 performed superbly in distinguishing CRC patients from controls (AUC = 0.947; 95% CI: 0.920-0.974, P < 0.0001, sensitivity: 80.67%, specificity: 100.00%), which showed much stronger performance than the traditional biomarkers (FOBT, CEA and CA19-9). Meanwhile, the fSYPL1 level positively correlated with tumor size, tumor invasion, lymph node invasion and clinical stage (P < 0.05). In addition, the detection rate of fSYPL1 was high in early CRC (75.00% in stage I and II). The fSYPL1 levels in CRC patients declined substantially after surgery (P = 0.0002). By means of a lower cut off level, 73.58% of high-risk adenomas were detected. The combination of fSYPL1 and FOBT performed better than the combination of plasma SYPL1, CEA and CA199 in distinguishing CRC patients from controls. CONCLUSION The fSYPL1 might be a potential biomarker for CRC screening, early diagnosis, prognosis prediction and therapeutic effect monitoring.
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Affiliation(s)
- Tao Shu
- Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan 646000, China
| | - Kaiwen Wu
- School of Medicine, Southwest Jiaotong University, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan 610031, China
| | - Yuanbiao Guo
- Medical Research Center, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, The Second Chengdu Affiliated Hospital of Chongqing Medical University, Chengdu, Sichuan 610031, China
| | - Qiao He
- Department of Clinical Laboratory, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan 610031, China
| | - Xiaoyu Song
- Department of Clinical Laboratory, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan 610031, China
| | - Jing Shan
- Department of Gastroenterology, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, The Second Chengdu Affiliated Hospital of Chongqing Medical University, Chengdu, Sichuan 610031, China
| | - Liping Wu
- Department of Gastroenterology, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, The Second Chengdu Affiliated Hospital of Chongqing Medical University, Chengdu, Sichuan 610031, China
| | - Jia Liu
- School of Medicine, Southwest Jiaotong University, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan 610031, China
| | - Zhiming Wang
- School of Medicine, Southwest Jiaotong University, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan 610031, China
| | - Lei Liu
- Medical Research Center, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, The Second Chengdu Affiliated Hospital of Chongqing Medical University, Chengdu, Sichuan 610031, China.
| | - Xiaobin Sun
- Department of Gastroenterology, Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan 646000, China; Department of Gastroenterology, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University, The Second Chengdu Affiliated Hospital of Chongqing Medical University, Chengdu, Sichuan 610031, China.
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Abstract
INTRODUCTION Colorectal cancer (CRC) is the second leading cause of cancer-related deaths globally. Nonetheless, with early detection of CRC or its precancerous lesions, mortality, and CRC incidence can be reduced. Although colonoscopy is currently the gold standard for CRC screening and diagnosis, its invasive nature, and troublesome bowel preparation deter patient participation. Therefore, there is a need to expand the use of noninvasive or minimally invasive methods to increase patient compliance. AREAS COVERED This review summarizes advances in different methods for CRC screening, including stool bacterial and metagenomic markers, fecal proteins, genetic and epigenetic markers in blood and stools, and imaging modalities. The cost-effectiveness of these methods is also discussed. FIT is more cost-effective compared to virtual colonoscopy, mSEPT9 test, and Multitarget Stool DNA test, while the cost-effectiveness of other noninvasive methods requires further evaluation. EXPERT OPINION Recent evidence has well demonstrated the usefulness of gut microbiome and certain fecal bacterial markers in the noninvasive diagnosis of CRC and its precancerous lesions. Many of the fecal biomarkers, from host cells or the gut environment, show better diagnostic sensitivity than FIT. New screening tests based on these fecal biomarkers can be expected to replace FIT with higher cost-effectiveness in the near future.
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Affiliation(s)
- Sarah Cheuk Hei Chan
- Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong, China
| | - Jessie Qiaoyi Liang
- Department of Medicine and Therapeutics, Li Ka Shing Institute of Health Sciences, Cuhk Shenzhen Research Institute, the Chinese University of Hong Kong, Shatin, Hong Kong, China
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19
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Lee B, Lin K, Liang PS. Effectiveness and Harms of Colorectal Cancer Screening Strategies. Gastrointest Endosc Clin N Am 2022; 32:215-226. [PMID: 35361332 DOI: 10.1016/j.giec.2021.12.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
Colorectal cancer screening incorporates various testing modalities. Factors including effectiveness, harms, cost, screening interval, patient preferences, and test availability should be considered when determining which test to use. Fecal occult blood testing and endoscopic screening have the most robust evidence, while newer blood- and imaging-based techniques require further evaluation. In this review, we compare the effectiveness, harms, and costs of the various screening strategies.
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Affiliation(s)
- Briton Lee
- Department of Medicine, NYU Langone Health, 550 First Avenue, NBV 16 North 30, New York, NY 10016, USA
| | - Kevin Lin
- Department of Medicine, NYU Langone Health, 550 First Avenue, NBV 16 North 30, New York, NY 10016, USA
| | - Peter S Liang
- Department of Medicine, NYU Langone Health, 550 First Avenue, NBV 16 North 30, New York, NY 10016, USA; Department of Medicine, VA New York Harbor Health Care System, 423 E 23rd Street, 11N, GI, New York, NY 10010, USA.
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20
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Li J, Zhang AH, Wu FF, Wang XJ. Alterations in the Gut Microbiota and Their Metabolites in Colorectal Cancer: Recent Progress and Future Prospects. Front Oncol 2022; 12:841552. [PMID: 35223525 PMCID: PMC8875205 DOI: 10.3389/fonc.2022.841552] [Citation(s) in RCA: 45] [Impact Index Per Article: 15.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/22/2021] [Accepted: 01/18/2022] [Indexed: 12/11/2022] Open
Abstract
Colorectal cancer (CRC) is a leading cause of cancer morbidity and mortality worldwide. The etiology and pathogenesis of CRC remain unclear. A growing body of evidence suggests dysbiosis of gut bacteria can contribute to the occurrence and development of CRC by generating harmful metabolites and changing host physiological processes. Metabolomics, a systems biology method, will systematically study the changes in metabolites in the physiological processes of the body, eventually playing a significant role in the detection of metabolic biomarkers and improving disease diagnosis and treatment. Metabolomics, in particular, has been highly beneficial in tracking microbially derived metabolites, which has substantially advanced our comprehension of host-microbiota metabolic interactions in CRC. This paper has briefly compiled recent research progress of the alterations of intestinal flora and its metabolites associated with CRC and the application of association analysis of metabolomics and gut microbiome in the diagnosis, prevention, and treatment of CRC; furthermore, we discuss the prospects for the problems and development direction of this association analysis in the study of CRC. Gut microbiota and their metabolites influence the progression and causation of CRC, and the association analysis of metabolomics and gut microbiome will provide novel strategies for the prevention, diagnosis, and therapy of CRC.
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Affiliation(s)
- Jing Li
- National Engineering Laboratory for the Development of Southwestern Endangered Medicinal Materials, Guangxi Botanical Garden of Medicinal Plant, Nanning, China
- National Chinmedomics Research Center, National Traditional Chinese Medicine (TCM) Key Laboratory of Serum Pharmacochemistry, Functional Metabolomics Laboratory, Department of Pharmaceutical Analysis, Heilongjiang University of Chinese Medicine, Harbin, China
| | - Ai-hua Zhang
- National Chinmedomics Research Center, National Traditional Chinese Medicine (TCM) Key Laboratory of Serum Pharmacochemistry, Functional Metabolomics Laboratory, Department of Pharmaceutical Analysis, Heilongjiang University of Chinese Medicine, Harbin, China
| | - Fang-fang Wu
- National Engineering Laboratory for the Development of Southwestern Endangered Medicinal Materials, Guangxi Botanical Garden of Medicinal Plant, Nanning, China
| | - Xi-jun Wang
- National Engineering Laboratory for the Development of Southwestern Endangered Medicinal Materials, Guangxi Botanical Garden of Medicinal Plant, Nanning, China
- National Chinmedomics Research Center, National Traditional Chinese Medicine (TCM) Key Laboratory of Serum Pharmacochemistry, Functional Metabolomics Laboratory, Department of Pharmaceutical Analysis, Heilongjiang University of Chinese Medicine, Harbin, China
- State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Macao, Macao SAR, China
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21
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Dysbiosis of human gut microbiome in young-onset colorectal cancer. Nat Commun 2021; 12:6757. [PMID: 34799562 PMCID: PMC8604900 DOI: 10.1038/s41467-021-27112-y] [Citation(s) in RCA: 136] [Impact Index Per Article: 34.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2020] [Accepted: 11/02/2021] [Indexed: 02/06/2023] Open
Abstract
The incidence of sporadic young-onset colorectal cancer (yCRC) is increasing. A significant knowledge gap exists in the gut microbiota and its diagnostic value for yCRC patients. Through 16S rRNA gene sequencing, 728 samples are collected to identify microbial markers, and an independent cohort of 310 samples is used to validate the results. Furthermore, species-level and functional analysis are performed by metagenome sequencing using 200 samples. Gut microbial diversity is increased in yCRC. Flavonifractor plautii is an important bacterial species in yCRC, while genus Streptococcus contains the key phylotype in the old-onset colorectal cancer. Functional analysis reveals that yCRC has unique characteristics of bacterial metabolism characterized by the dominance of DNA binding and RNA-dependent DNA biosynthetic process. The random forest classifier model achieves a powerful classification potential. This study highlights the potential of the gut microbiota biomarkers as a promising non-invasive tool for the accurate detection and distinction of individuals with yCRC.
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22
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Brar B, Ranjan K, Palria A, Kumar R, Ghosh M, Sihag S, Minakshi P. Nanotechnology in Colorectal Cancer for Precision Diagnosis and Therapy. FRONTIERS IN NANOTECHNOLOGY 2021. [DOI: 10.3389/fnano.2021.699266] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Abstract
Colorectal cancer (CRC) is the third most frequently occurring tumor in the human population. CRCs are usually adenocarcinomatous and originate as a polyp on the inner wall of the colon or rectum which may become malignant in the due course of time. Although the therapeutic options of CRC are limited, the early diagnosis of CRC may play an important role in preventive and therapeutic interventions to decrease the mortality rate. The CRC-affected tissues exhibit several molecular markers that may be exploited as the novel strategy to develop newer approaches for the treatment of the disease. Nanotechnology consists of a wide array of innovative and astonishing nanomaterials with both diagnostics and therapeutic potential. Several nanomaterials and nano formulations such as Carbon nanotubes, Dendrimer, Liposomes, Silica Nanoparticles, Gold nanoparticles, Metal-organic frameworks, Core-shell polymeric nano-formulations, Nano-emulsion System, etc can be used to targeted anticancer drug delivery and diagnostic purposes in CRC. The light-sensitive photosensitizer drugs loaded gold and silica nanoparticles can be used to diagnose as well as the killing of CRC cells by the targeted delivery of anticancer drugs to cancer cells. This review is focused on the recent advancement of nanotechnology in the diagnosis and treatment of CRC.
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Abstract
Mortality from colorectal cancer is reduced through screening and early detection; moreover, removal of neoplastic lesions can reduce cancer incidence. While understanding of the risk factors, pathogenesis, and precursor lesions of colorectal cancer has advanced, the cause of the recent increase in cancer among young adults is largely unknown. Multiple invasive, semi- and non-invasive screening modalities have emerged over the past decade. The current emphasis on quality of colonoscopy has improved the effectiveness of screening and prevention, and the role of new technologies in detection of neoplasia, such as artificial intelligence, is rapidly emerging. The overall screening rates in the US, however, are suboptimal, and few interventions have been shown to increase screening uptake. This review provides an overview of colorectal cancer, the current status of screening efforts, and the tools available to reduce mortality from colorectal cancer.
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Affiliation(s)
- Priyanka Kanth
- Division of Gastroenterology, University of Utah, Salt Lake City, UT, USA
- Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA
| | - John M Inadomi
- Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA
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Green BB, Baldwin LM, West II, Schwartz M, Coronado GD. Low Rates of Colonoscopy Follow-up After a Positive Fecal Immunochemical Test in a Medicaid Health Plan Delivered Mailed Colorectal Cancer Screening Program. J Prim Care Community Health 2021; 11:2150132720958525. [PMID: 32912056 PMCID: PMC7488888 DOI: 10.1177/2150132720958525] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Follow-up colonoscopy after a positive fecal immunochemical test (FIT) is necessary for colorectal cancer (CRC) screening to be effective. We report colonoscopy follow-up rates after a positive FIT overall and by population characteristics in the BeneFIT demonstration pilot, a Medicaid health insurance plan-delivered mailed FIT outreach program. METHODS In 2016, 2 health insurance plans in Oregon and in Washington state mailed FIT kits to Medicaid patients who, based on claims data, were overdue for CRC screening. We report follow-up colonoscopy completion rates after positive FIT, and differences in completion rates by age, sex, race, ethnicity, preferred language, and number of primary care visits in the prior year. This research was human subjects approved with a waiver of consent for data collection. RESULTS The FIT positivity rates in Health Plan Oregon and Health Plan Washington were 7.9% (39/488) and 14.6% (125/857), respectively. Colonoscopy completion rates within 12 months of the positive test were 35.9% (14/41) in Health Plan Oregon and 32.8% (41/125) in Health Plan Washington. Colonoscopy completion rates were higher among individuals who preferred a language other than English (Non-English speakers 70.0%, English speakers 31.3%, P = .04). CONCLUSION In a health plan-delivered mailed FIT outreach program, follow-up colonoscopy rates after a positive test were low. Additional interventions are needed to assure colonoscopy after a positive FIT test and to reap the benefits of screening.
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Affiliation(s)
- Beverly B Green
- Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA
| | | | | | | | - Gloria D Coronado
- Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA
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Lin JS, Perdue LA, Henrikson NB, Bean SI, Blasi PR. Screening for Colorectal Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA 2021; 325:1978-1998. [PMID: 34003220 DOI: 10.1001/jama.2021.4417] [Citation(s) in RCA: 336] [Impact Index Per Article: 84.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
IMPORTANCE Colorectal cancer (CRC) remains a significant cause of morbidity and mortality in the US. OBJECTIVE To systematically review the effectiveness, test accuracy, and harms of screening for CRC to inform the US Preventive Services Task Force. DATA SOURCES MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials for relevant studies published from January 1, 2015, to December 4, 2019; surveillance through March 26, 2021. STUDY SELECTION English-language studies conducted in asymptomatic populations at general risk of CRC. DATA EXTRACTION AND SYNTHESIS Two reviewers independently appraised the articles and extracted relevant study data from fair- or good-quality studies. Random-effects meta-analyses were conducted. MAIN OUTCOMES AND MEASURES Colorectal cancer incidence and mortality, test accuracy in detecting cancers or adenomas, and serious adverse events. RESULTS The review included 33 studies (n = 10 776 276) on the effectiveness of screening, 59 (n = 3 491 045) on the test performance of screening tests, and 131 (n = 26 987 366) on the harms of screening. In randomized clinical trials (4 trials, n = 458 002), intention to screen with 1- or 2-time flexible sigmoidoscopy vs no screening was associated with a decrease in CRC-specific mortality (incidence rate ratio, 0.74 [95% CI, 0.68-0.80]). Annual or biennial guaiac fecal occult blood test (gFOBT) vs no screening (5 trials, n = 419 966) was associated with a reduction of CRC-specific mortality after 2 to 9 rounds of screening (relative risk at 19.5 years, 0.91 [95% CI, 0.84-0.98]; relative risk at 30 years, 0.78 [95% CI, 0.65-0.93]). In observational studies, receipt of screening colonoscopy (2 studies, n = 436 927) or fecal immunochemical test (FIT) (1 study, n = 5.4 million) vs no screening was associated with lower risk of CRC incidence or mortality. Nine studies (n = 6497) evaluated the test accuracy of screening computed tomography (CT) colonography, 4 of which also reported the test accuracy of colonoscopy; pooled sensitivity to detect adenomas 6 mm or larger was similar between CT colonography with bowel prep (0.86) and colonoscopy (0.89). In pooled values, commonly evaluated FITs (14 studies, n = 45 403) (sensitivity, 0.74; specificity, 0.94) and stool DNA with FIT (4 studies, n = 12 424) (sensitivity, 0.93; specificity, 0.85) performed better than high-sensitivity gFOBT (2 studies, n = 3503) (sensitivity, 0.50-0.75; specificity, 0.96-0.98) to detect cancers. Serious harms of screening colonoscopy included perforations (3.1/10 000 procedures) and major bleeding (14.6/10 000 procedures). CT colonography may have harms resulting from low-dose ionizing radiation. It is unclear if detection of extracolonic findings on CT colonography is a net benefit or harm. CONCLUSIONS AND RELEVANCE There are several options to screen for colorectal cancer, each with a different level of evidence demonstrating its ability to reduce cancer mortality, its ability to detect cancer or precursor lesions, and its risk of harms.
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Affiliation(s)
- Jennifer S Lin
- Kaiser Permanente Evidence-based Practice Center, Center for Health Research, Kaiser Permanente, Portland, Oregon
| | - Leslie A Perdue
- Kaiser Permanente Evidence-based Practice Center, Center for Health Research, Kaiser Permanente, Portland, Oregon
| | - Nora B Henrikson
- Kaiser Permanente Evidence-based Practice Center, Center for Health Research, Kaiser Permanente, Portland, Oregon
| | - Sarah I Bean
- Kaiser Permanente Evidence-based Practice Center, Center for Health Research, Kaiser Permanente, Portland, Oregon
| | - Paula R Blasi
- Kaiser Permanente Evidence-based Practice Center, Center for Health Research, Kaiser Permanente, Portland, Oregon
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Benton SC, Piggott C, Blyuss O, Li SJ, Mathews C, Carroll M, Duffy S. Impact of changing from a guaiac faecal occult blood test to a faecal immunochemical test in a national screening programme: Results from a pilot study within the national bowel cancer screening programme in England. J Med Screen 2021; 28:426-432. [PMID: 33983066 DOI: 10.1177/09691413211013376] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
OBJECTIVE Testing for occult blood in faeces is widely used in bowel cancer screening around the world. In many programmes, the faecal immunochemical test (FIT) is replacing the traditional guiaic faecal occult blood test (gFOBT). There have been a number of reports on the clinical impact of making this change; yet, no-one has considered the pre-analytical and analytical impact of moving from a gFOBT to a FIT bowel cancer screening programme. METHODS We interrogated data obtained in a FIT pilot carried out in England in 2014 to assess the timeliness of specimen collection device return time and analysis for gFOBT and FIT, the impact of time to analysis on faecal haemoglobin (f-Hb) concentration, and any differences observed between analyses carried out at two different testing laboratories. RESULTS FIT kits were returned on average 5.6 days sooner than gFOBT. The time to analysis for FIT leads to an overall rise in f-Hb concentration within the manufacturer's stated 14-day stability period. CONCLUSION Both these factors are important considerations for laboratories when considering setting up a bowel cancer screening programme, especially if transitioning from gFOBT to FIT. Our data also support previous evidence of males having a higher f-Hb than females and demonstrate that after adjusting for sex, age and screening hub, neither index of multiple deprivation nor screening episode significantly affected f-Hb.
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Affiliation(s)
- Sally C Benton
- Department of Clinical Biochemistry, Royal Surrey County Hospital, Berkshire and Surrey Pathology Services, Guildford, Surrey, UK.,NHS Bowel Cancer Screening South of England Hub, Berkshire and Surrey Pathology Services, Royal Surrey County Hospital, Guildford, Surrey, UK
| | - Carolyn Piggott
- NHS Bowel Cancer Screening South of England Hub, Berkshire and Surrey Pathology Services, Royal Surrey County Hospital, Guildford, Surrey, UK
| | - Oleg Blyuss
- Department of Paediatrics and Paediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.,School of Physics, Astronomy and Mathematics, University of Hertfordshire, College Lane, Hatfield, UK
| | - Shuping J Li
- Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK
| | - Christopher Mathews
- School of Cancer and Pharmaceutical Sciences, King's College London, London, UK
| | - Magdalen Carroll
- NHS Bowel Cancer Screening South of England Hub, Berkshire and Surrey Pathology Services, Royal Surrey County Hospital, Guildford, Surrey, UK
| | - Stephen Duffy
- Department of Clinical Biochemistry, Royal Surrey County Hospital, Berkshire and Surrey Pathology Services, Guildford, Surrey, UK.,Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK
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Smith RA, Fedewa S, Siegel R. Early colorectal cancer detection-Current and evolving challenges in evidence, guidelines, policy, and practices. Adv Cancer Res 2021; 151:69-107. [PMID: 34148621 DOI: 10.1016/bs.acr.2021.03.005] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
The understanding at the beginning of the last century that colorectal cancer began as a localized disease that progressed and became systemic, and that most colorectal cancer arose from adenomatous polyps gave rise to aggressive attempts at curative treatment and eventually attempts to detect advanced lesions before they progressed to invasive disease. In the last four decades, steadily greater uptake of screening has led to reductions in colorectal cancer incidence and mortality. However, the fullest potential of screening is not being met due to the lack of organized screening, where a systems approach could lead to higher rates of screening of average and high risk groups, higher quality screening, and prompt followup of adults with positive screening tests. ABSTRACT: Since the beginning of the 20th century, there has been a general understanding that colorectal cancer is a clonal disease that progresses from a localized stage with a favorable prognosis through progressively more advanced stages which have progressively worse prognosis. That understanding led first to determined efforts to detect and treat early stage symptomatic disease, and then to detect pre-symptomatic colorectal cancer and precursor lesions, where there was hope that the natural history of the disease could be arrested and the incidence and premature mortality of colorectal cancer averted. Toward the end of the last century, guidelines for colorectal cancer screening, growth in the number of technical options for screening, and a steady increase in the proportion of the adult population who attended screening contributed to the beginning of a significant decline in colorectal cancer incidence and mortality. Despite this progress, colorectal cancer remains the third leading cause of death among men and women in the United States. Screening for early detection of precursor lesions and localized cancer offers the single most productive opportunity to further reduce the burden of disease, and yet nearly four in five deaths from colorectal cancer are associated with having never been screened, not recently screened, or not followed up for an abnormal screening test. This simple observation is a call to action in all communities to apply existing knowledge to fulfill the potential to prevent avertable incidence and mortality.
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Affiliation(s)
- Robert A Smith
- Cancer Prevention and Early Detection Department, American Cancer Society, Atlanta, GA, United States.
| | - Stacey Fedewa
- Screening and Risk Factors Research, Surveillance and Health Equity Science Department, American Cancer Society, Atlanta, GA, United States
| | - Rebecca Siegel
- Surveillance Research, Surveillance and Health Equity Science Department, American Cancer Society, Atlanta, GA, United States
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Cao Y, Zhao G, Cao Y, Chen Z, Liu X, Yuan M, Yang J, Wang X, Ma Y, Liu Z, Xiong S, Zheng M, Fei S. Feasibility of Methylated CLIP4 in Stool for Early Detection of Colorectal Cancer: A Training Study in Chinese Population. Front Oncol 2021; 11:647066. [PMID: 33968748 PMCID: PMC8100593 DOI: 10.3389/fonc.2021.647066] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/29/2020] [Accepted: 04/01/2021] [Indexed: 12/19/2022] Open
Abstract
BACKGROUND Early detection of colorectal cancer (CRC) and precancerous lesion is vitally important for mitigating CRC morbidity and mortality. Aberrant DNA methylations in certain promoter regions have been identified to be closely associated with CRC development and progression, suggesting their potential as diagnostic biomarkers for early detection. In this study, we evaluated the performance of methylated CLIP4 in stool specimens as a potential biomarker for CRC detection. METHODS A total of 321 subjects out of 365 enrolled participants were included in the final analysis, including 154 CRC patients, 23 advanced adenoma (AA) patients, 49 small polyp (SP) patients, and 95 healthy controls. CLIP4 methylation level was examined by qPCR with bisulfite converted DNA purified from approximately 5 g stool specimen. RESULTS Methylated CLIP4 test showed high sensitivities of 78.3% (95% CI: 55.8%-91.7%) and 90.3% (95% CI: 84.2%-94.3%) for detecting AA and CRC, respectively, with a specificity of 88.4% (95% CI: 79.8%-93.8%). CLIP4 methylation level discriminated AA and CRC patients from control subjects with area under the curve values of 0.892 (95% CI: 0.795-0.988) and 0.961 (95% CI: 0.938-0.983). Further analysis indicated no significant difference in sensitivities among different ages, genders, stages, locations, sides, tumor sizes and differentiation statuses. CONCLUSIONS Methylated CLIP4 showed a strong potential as a noninvasive biomarker for early CRC detection.
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Affiliation(s)
- Yang Cao
- Department of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
- Institute of Digestive Diseases, Xuzhou Medical University, Xuzhou, China
| | - Guodong Zhao
- Zhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, China
- State Key Laboratory of Bioelectronics, School of Biological Science and Medical Engineering, Southeast University, Nanjing, China
- Department of R&D, Suzhou VersaBio Technologies Co. Ltd., Kunshan, China
| | - Yaping Cao
- Department of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
- Institute of Digestive Diseases, Xuzhou Medical University, Xuzhou, China
| | - Zhiliang Chen
- Department of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
- Institute of Digestive Diseases, Xuzhou Medical University, Xuzhou, China
| | - Xiaoyu Liu
- Zhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, China
| | - Mufa Yuan
- Department of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
- Institute of Digestive Diseases, Xuzhou Medical University, Xuzhou, China
| | - Jun Yang
- Department of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
- Institute of Digestive Diseases, Xuzhou Medical University, Xuzhou, China
| | - Xiaomei Wang
- Zhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, China
| | - Yong Ma
- Zhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, China
- Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou, China
| | - Zhaocheng Liu
- Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou, China
| | - Shangmin Xiong
- Zhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, China
- Department of R&D, Suzhou VersaBio Technologies Co. Ltd., Kunshan, China
| | - Minxue Zheng
- Zhejiang University Kunshan Biotechnology Laboratory, Zhejiang University Kunshan Innovation Institute, Kunshan, China
- Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou, China
| | - Sujuan Fei
- Department of Gastroenterology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
- Institute of Digestive Diseases, Xuzhou Medical University, Xuzhou, China
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PPV and Detection Rate of mt-sDNA Testing, FIT, and CT Colonography for Advanced Neoplasia: A Hierarchic Bayesian Meta-Analysis of the Noninvasive Colorectal Screening Tests. AJR Am J Roentgenol 2021; 217:817-830. [PMID: 33703913 DOI: 10.2214/ajr.20.25416] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND. Noninvasive tests for colorectal cancer (CRC) screening and prevention limit the need for invasive colonoscopy to follow up positive test results. However, the relative performance characteristics of available noninvasive tests have not yet been adequately compared. OBJECTIVE. We performed a systematic review and meta-analysis to compare the diagnostic performance of the available noninvasive CRC screening tests, including multitarget stool DNA (mt-sDNA) testing, fecal immunochemical testing (FIT), and CT colonography (CTC), with an emphasis on comparison of PPV and detection rate (DR) for advanced neoplasia (AN; encompassing cases of advanced adenomas and CRC). EVIDENCE ACQUISITION. After systematic searches of MEDLINE and Google Scholar databases, 10 mt-sDNA, 27 CTC, and 88 FIT published screening studies involving 25,132, 33,493, and 2,355,958 asymptomatic adults, respectively, were included. Meta-analysis with hierarchic Bayesian modeling was conducted in accordance with Cochrane Collaboration and PRISMA guidelines to determine test positivity rates (TPRs) leading to optical colonoscopy, as well as PPVs and DRs for both AN and CRC. Different positivity thresholds were considered for FIT and CTC. EVIDENCE SYNTHESIS. Point estimates (with 95% credible intervals) from pooled Bayesian meta-analysis combining all thresholds for FIT and stratifying CTC results by a polyp size threshold of 6 mm or larger (CTC6) and 10 mm or larger (CTC10) were calculated. TPR was 13.5% (10.9-16.6%) for mt-sDNA testing, 6.4% (5.8-7.2%) for FIT, 13.4% (11.4-15.6%) for CTC6, and 6.6% (5.2-7.7%) for CTC10. AN PPV was 26.9% (95% credible interval, 21.8-33.2%) for mt-sDNA testing, 31.8% (29.3-34.5%) for FIT, 34.4% (27.2-41.0%) for CTC6, and 61.0% (54.0-70.0%) for CTC10. CRC PPV was 2.4% (1.5-3.9%) for mt-sDNA testing, 4.9% (4.3-5.3%) for FIT, 3.5% (2.5-4.8%) for CTC6, and 6.0% (4.3-8.0%) for CTC10. The DR for AN was 3.4% (95% credible interval, 2.5-4.8%) for mt-SDNA, 2.0% (1.8-2.3%) for FIT, 4.8% (4.0-6.5%) for CTC6, and 4.0% (3.0-4.6%) for CTC10. When FIT is restricted to a lower threshold (< 10 μg Hb/g feces), its performance profile is similar to that of mt-sDNA testing, although available data are limited. AN PPV odds ratios (relative to CTC10 as the reference) were 0.24 (95% credible interval, 0.17-0.33) for mt-sDNA testing, 0.30 (0.24-0.45) for FIT, and 0.33 (0.25-0.47) for CTC6. CONCLUSION. Among noninvasive CRC screening tests, CTC with a polyp size threshold of 10 mm or larger most effectively targets AN, preserving detection while also decreasing unnecessary colonoscopies compared with mt-sDNA testing and FIT. CLINICAL IMPACT. CTC performed with a polyp size threshold for colonoscopy referral set at 10 mm or larger represents the most effective and efficient noninvasive screening test for CRC prevention and detection.
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Advani D, Sharma S, Kumari S, Ambasta RK, Kumar P. Precision Oncology, Signaling and Anticancer Agents in Cancer Therapeutics. Anticancer Agents Med Chem 2021; 22:433-468. [PMID: 33687887 DOI: 10.2174/1871520621666210308101029] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/21/2020] [Revised: 01/05/2021] [Accepted: 01/12/2021] [Indexed: 11/22/2022]
Abstract
BACKGROUND The global alliance for genomics and healthcare facilities provides innovational solutions to expedite research and clinical practices for complex and incurable health conditions. Precision oncology is an emerging field explicitly tailored to facilitate cancer diagnosis, prevention and treatment based on patients' genetic profile. Advancements in "omics" techniques, next-generation sequencing, artificial intelligence and clinical trial designs provide a platform for assessing the efficacy and safety of combination therapies and diagnostic procedures. METHOD Data were collected from Pubmed and Google scholar using keywords: "Precision medicine", "precision medicine and cancer", "anticancer agents in precision medicine" and reviewed comprehensively. RESULTS Personalized therapeutics including immunotherapy, cancer vaccines, serve as a groundbreaking solution for cancer treatment. Herein, we take a measurable view of precision therapies and novel diagnostic approaches targeting cancer treatment. The contemporary applications of precision medicine have also been described along with various hurdles identified in the successful establishment of precision therapeutics. CONCLUSION This review highlights the key breakthroughs related to immunotherapies, targeted anticancer agents, and target interventions related to cancer signaling mechanisms. The success story of this field in context to drug resistance, safety, patient survival and in improving quality of life is yet to be elucidated. We conclude that, in the near future, the field of individualized treatments may truly revolutionize the nature of cancer patient care.
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Affiliation(s)
- Dia Advani
- Molecular Neuroscience and Functional Genomics Laboratory Shahbad Daulatpur, Bawana Road, Delhi 110042. India
| | - Sudhanshu Sharma
- Molecular Neuroscience and Functional Genomics Laboratory Shahbad Daulatpur, Bawana Road, Delhi 110042. India
| | - Smita Kumari
- Molecular Neuroscience and Functional Genomics Laboratory Shahbad Daulatpur, Bawana Road, Delhi 110042. India
| | - Rashmi K Ambasta
- Molecular Neuroscience and Functional Genomics Laboratory Shahbad Daulatpur, Bawana Road, Delhi 110042. India
| | - Pravir Kumar
- Molecular Neuroscience and Functional Genomics Laboratory Shahbad Daulatpur, Bawana Road, Delhi 110042. India
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ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol 2021; 116:458-479. [PMID: 33657038 DOI: 10.14309/ajg.0000000000001122] [Citation(s) in RCA: 420] [Impact Index Per Article: 105.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2020] [Accepted: 12/02/2020] [Indexed: 12/11/2022]
Abstract
Colorectal cancer (CRC) is the third most common cancer in men and women in the United States. CRC screening efforts are directed toward removal of adenomas and sessile serrated lesions and detection of early-stage CRC. The purpose of this article is to update the 2009 American College of Gastroenterology CRC screening guidelines. The guideline is framed around several key questions. We conducted a comprehensive literature search to include studies through October 2020. The inclusion criteria were studies of any design with men and women age 40 years and older. Detailed recommendations for CRC screening in average-risk individuals and those with a family history of CRC are discussed. We also provide recommendations on the role of aspirin for chemoprevention, quality indicators for colonoscopy, approaches to organized CRC screening and improving adherence to CRC screening. CRC screening must be optimized to allow effective and sustained reduction of CRC incidence and mortality. This can be accomplished by achieving high rates of adherence, quality monitoring and improvement, following evidence-based guidelines, and removing barriers through the spectrum of care from noninvasive screening tests to screening and diagnostic colonoscopy. The development of cost-effective, highly accurate, noninvasive modalities associated with improved overall adherence to the screening process is also a desirable goal.
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Su WC, Kao WY, Chang TK, Tsai HL, Huang CW, Chen YC, Li CC, Hsieh YC, Yeh HJ, Chang CC, Wang JY. Stool DNA test targeting methylated syndecan-2 (SDC2) as a noninvasive screening method for colorectal cancer. Biosci Rep 2021; 41:BSR20201930. [PMID: 33393623 PMCID: PMC7809545 DOI: 10.1042/bsr20201930] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2020] [Revised: 12/01/2020] [Accepted: 12/24/2020] [Indexed: 12/24/2022] Open
Abstract
Despite the steadily increasing worldwide incidence of colorectal cancer (CRC), an effective noninvasive approach for early detection of CRC is still under investigation. The guaiac-based fecal occult blood test (FOBT) and fecal immunochemical test (FIT) have gained popularity as noninvasive CRC screening tests owing to their convenience and relatively low costs. However, the FOBT and FIT have limited sensitivity and specificity. To develop a noninvasive tool for the detection of CRC, we investigated the sensitivity, specificity, and accuracy of a stool DNA test targeting methylated syndecan-2 (SDC2), which is frequently methylated in patients with CRC. The present study enrolled 62 patients diagnosed as having stage 0-IV CRC and 76 healthy participants between July 2018 and June 2019 from two institutions. Approximately 4.5 g of stool sample was collected from each participant for detection of human methylated SDC2 gene. In total, 48 of 62 (77.4%) patients with CRC showed positive results, whereas 67 out of 76 (88.2%) healthy participants showed negative results. The area under the curve of the receiver operating characteristic curve constructed was 0.872 for discrimination between patients with CRC and healthy individuals. The present study highlights the potential of the fecal methylated SDC2 test as a noninvasive detection method for CRC screening with a relatively favorable sensitivity of 77.4%, a specificity of 88.2% and a positive predictive value of 84.2% compared with other available fecal tests. Further multicenter clinical trials comprising subjects of varied ethnicities are required to validate this test for the mass screening of patients with CRC.
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Affiliation(s)
- Wei-Chih Su
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
- Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Wei-Yu Kao
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
| | - Tsung-Kun Chang
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
- Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Hsiang-Lin Tsai
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
- Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Ching-Wen Huang
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
- Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Yen-Cheng Chen
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Ching-Chun Li
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Yi-Chien Hsieh
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Hsing-Jung Yeh
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
| | - Chun-Chao Chang
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan
| | - Jaw-Yuan Wang
- Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
- Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
- Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
- Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
- Center for Cancer Research, Kaohsiung Medical University, Kaohsiung, Taiwan
- Cohort Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan
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33
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Mattar R, Marques SB, Minata MK, Silva-Etto JMKD, Sakai P, DE Moura EGH. DIAGNOSTIC ACCURACY OF ONE SAMPLE OR TWO SAMPLES QUANTITATIVE FECAL IMMUNOCHEMICAL TESTS FOR INTESTINAL NEOPLASIA DETECTION. ARQUIVOS DE GASTROENTEROLOGIA 2020; 57:316-322. [PMID: 32935747 DOI: 10.1590/s0004-2803.202000000-58] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/08/2020] [Accepted: 06/05/2020] [Indexed: 11/22/2022]
Abstract
BACKGROUND Rectal bleeding is the most important symptom of intestinal neoplasia; thus, tests of occult blood detection in stools are widely used for pre neoplastic lesions and colorectal cancer (CRC) screening. OBJECTIVE Evaluate the accuracy of OC-Sensor quantitative test (Eiken Chemical, Tokyo, Japan) at cut-off 10 µg Hb/g feces (50 ng/mL) in a cohort of subjects that had to undergo diagnostic colonoscopy, and if more than one sample collected in consecutive days would improve the diagnostic accuracy of the test. METHODS Patients (mean age 56.3±9.7 years) that underwent colonoscopy prospectively randomly received one (1-sample FIT, FIT 1) or two (2-sample FIT, FIT 2) collection tubes. They collected the stool sample before starting colonoscopy preparation. Samples were analyzed by the OC-Auto Micro 80 (Eiken Chemical, Tokyo, Japan). The performance of FIT 1 and FIT 2 were compared to the colonoscopy findings. RESULTS Among 289 patients, CRC was diagnosed in 14 (4.8%), advanced adenoma in 37 (12.8%), early adenoma in 71 (24.6%) and no abnormalities in 141 (48.8%). For FIT 1, the sensitivity for CRC was 83.3% (95%CI 36.5-99.1%), for advanced adenoma was 24% (95%CI 10.1-45.5%), with specificity of 86.9% (95%CI 77.3-92.9%). For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%). The positive likelihood ratios were 1.8 (95%CI 0.7-4.4 for FIT 1) and 7.1 (95%CI 2.4-21.4 for FIT 2) for advanced adenoma, and 6.4 (95%CI 3.3-12.3, for FIT 1) and 10.7 (95%CI 3.8-29.8, for FIT 2) for CRC. The negative likelihood ratio were 0.9 (95%CI 0.7-1, for FIT 1) and 0.5 (95%CI 0.3-0.9, for FIT 2) for advanced adenoma, and 0.2 (0.03-1.1, for FIT 1) and 0.3 (0.08-0.9, for FIT 2) for CRC. The differences between FIT 1 and FIT 2 performances were not significant. However, the comparison of the levels of hemoglobin in feces of patients of FIT 1 and FIT 2 showed that the differences between no polyp group and advanced adenoma and CRC were significant. CONCLUSION The accuracy of OCR Sensor with 10 µg Hb/g feces cut-off was comparable to other reports and two-sample collection improved the detection rate of advanced adenoma, a pre neoplastic condition to prevent CRC incidence.
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Affiliation(s)
- Rejane Mattar
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Gastroenterologia e Hepatologia Clínica, São Paulo, SP, Brasil
| | - Sergio Barbosa Marques
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil
| | - Maurício Kazuyoshi Minata
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil
| | - Joyce Matie Kinoshita da Silva-Etto
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Gastroenterologia e Hepatologia Clínica, São Paulo, SP, Brasil
| | - Paulo Sakai
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil
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34
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Spies KE, Slovak JE. Pilot study of the effect of gastrointestinal diets on fecal occult blood testing in cats. J Feline Med Surg 2020; 22:656-663. [PMID: 31509050 PMCID: PMC10814429 DOI: 10.1177/1098612x19873151] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
OBJECTIVES The aim of this study was to assess the methodology of guaiac-based fecal occult blood (FOB) testing in healthy cats, and to examine the effect of feeding selected gastrointestinal diets (canned and dry) on FOB results. METHODS Stool obtained from three cats was mixed with incremental quantities of EDTA whole blood. FOB tests were performed in triplicate and interpreted at 5 mins, and at 24, 48 and 72 h post-test set-up. Ten cats were fed their normal diets, a dry hydrolyzed protein diet, a dry gastrointestinal diet and then transitioned back to their normal diet over a 7-week period. A subsequent study was repeated with similar hydrolyzed protein and gastrointestinal canned diets. Two fecal samples were tested per cat each week using human point-of-care guaiac tests. RESULTS Ten microliters of whole feline blood could be reliably detected in feline stool at all time points evaluated. There was no evidence of an association between the dry hydrolyzed and dry gastrointestinal diets and a positive FOB test result (P = 0.33). Cats fed a canned gastrointestinal diet had a significantly higher probability of producing a positive FOB result than when on their normal diet (P <0.01). Feeding the canned hydrolyzed diet was not associated with an increased probability of a positive FOB test vs the normal diet (P = 0.94). CONCLUSIONS AND RELEVANCE Small amounts of blood in feline stool can be reliably and repeatedly detected as early as 5 mins post-FOB test set-up, making this a user-friendly bench-top screening test in a veterinary setting. Cats fed a single dry hydrolyzed, dry gastroenteric or canned hydrolyzed diet in this study had a low chance of false-positive FOB test results, while those fed the canned gastrointestinal diet had a significantly greater likelihood of producing false-positive results.
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Affiliation(s)
- Kate E Spies
- Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Washington State University, Pullman, WA, USA
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35
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Voronova V, Glybochko P, Svistunov A, Fomin V, Kopylov P, Tzarkov P, Egorov A, Gitel E, Ragimov A, Boroda A, Poddubskaya E, Sekacheva M. Diagnostic Value of Combinatorial Markers in Colorectal Carcinoma. Front Oncol 2020; 10:832. [PMID: 32528895 PMCID: PMC7258084 DOI: 10.3389/fonc.2020.00832] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/22/2019] [Accepted: 04/28/2020] [Indexed: 12/17/2022] Open
Abstract
Objectives: Blood-based tests have been shown to be an effective strategy for colorectal cancer (CRC) detection in screening programs. This study was aimed to test the performance of 20 blood markers including tumor antigens, inflammatory markers, and apolipoproteins as well as their combinations. Methods: In total 203 healthy volunteers and 102 patients with CRC were enrolled into the study. Differences between healthy and cancer subjects were evaluated using Wilcoxon rank-sum test. Several multivariate classification algorithms were employed using information about different combinations of biomarkers altered in CRC patients as well as age and gender of the subjects; random sub-sampling cross-validation was done to overcome overfitting problem. Diagnostic performance of single biomarkers and multivariate classification models was evaluated by receiver operating characteristic (ROC) analysis. Results: Of 20 biomarkers, 16 were significantly different between the groups (p-value ≤ 0.001); ApoA1, ApoA2 and ApoA4 levels were decreased, whereas levels of tumor antigens (e.g. carcinoembriogenic antigen) and inflammatory markers (e.g., C-reactive protein) were increased in CRC patients vs. healthy subjects. Combinatorial markers including information about all 16 significant analytes, age and gender of patients, demonstrated better performance over single biomarkers with average accuracy on test datasets ≥95% and area under ROC curve (AUROC) ≥98%. Conclusions: Combinatorial approach was shown to be a valid strategy to improve performance of blood-based CRC diagnostics. Further evaluation of the proposed models in screening programs will be performed to gain a better understanding of their diagnostic value.
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Affiliation(s)
| | - Peter Glybochko
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | - Andrey Svistunov
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | - Viktor Fomin
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | - Philipp Kopylov
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | - Peter Tzarkov
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | - Alexey Egorov
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | - Evgenij Gitel
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | | | - Alexander Boroda
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
| | | | - Marina Sekacheva
- I.M. Sechenov First Moscow State Medical University, Moscow, Russia
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36
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Making FIT Count: Maximizing Appropriate Use of the Fecal Immunochemical Test for Colorectal Cancer Screening Programs. J Gen Intern Med 2020; 35:1870-1874. [PMID: 32128688 PMCID: PMC7280423 DOI: 10.1007/s11606-020-05728-y] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2019] [Accepted: 02/10/2020] [Indexed: 02/06/2023]
Abstract
Colorectal cancer (CRC) remains one of the most common and deadly malignancies despite advancements in screening, diagnostic capabilities, and treatment. The ability to detect and remove precancerous and cancerous lesions via screening has altered the epidemiology of the disease, decreasing incidence, mortality, and late-stage disease presentation. The fecal immunochemical test (FIT) is a screening test that aims to detect human hemoglobin in the stool. FIT is the most common CRC screening modality worldwide and second most common in the United States. Its use in screening programs has been shown to increase screening uptake and improve CRC outcomes. However, FIT-based screening programs vary widely in quality and effectiveness. In health systems with high-quality FIT screening programs, only superior FIT formats are used, providers order FIT appropriately, annual patient participation is high, and diagnostic follow-up after an abnormal result is achieved in a timely manner. Proper utilization of FIT involves multiple steps beyond provider recommendation of the test. In this commentary, we aim to highlight ongoing challenges in FIT screening and suggest interventions to maximize FIT effectiveness. Through active engagement of patients and providers, health systems can use FIT to help optimize CRC screening rates and improve CRC outcomes.
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Cardoso R, Guo F, Heisser T, Hoffmeister M, Brenner H. Utilisation of Colorectal Cancer Screening Tests in European Countries by Type of Screening Offer: Results from the European Health Interview Survey. Cancers (Basel) 2020; 12:cancers12061409. [PMID: 32486077 PMCID: PMC7352919 DOI: 10.3390/cancers12061409] [Citation(s) in RCA: 47] [Impact Index Per Article: 9.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2020] [Revised: 05/22/2020] [Accepted: 05/27/2020] [Indexed: 12/24/2022] Open
Abstract
In the past two decades, an extensive rollout of colorectal cancer (CRC) screening programmes has been initiated in European countries with a large heterogeneity of screening offers. Using data from a population-based cross-sectional survey conducted between 2013 and 2016 in all European Union countries, we analysed the utilisation of faecal tests and colonoscopy among people aged 50–74 years and the factors associated with uptake by type of screening offer. We observed the highest utilisation of either test for countries with fully rolled out organised programmes with faecal tests (ranging from 29.7% in Croatia to 66.7% in the UK) and countries offering both faecal tests and colonoscopy (from 22.7% in Greece to 70.9% in Germany). Utilisation was very low for countries with no programme (from 6.3% in Romania to 30.5% in Norway). Younger age (50–54 years), longer time since last consultation with a doctor and a lifestyle score associated with increased CRC risk were significantly associated with lower test use, a pattern observed across all types of screening offers. Our results suggest that more countries should implement organised programmes with faecal immunochemical tests, in combination with alternative endoscopy offers where resources allow. Furthermore, there is a large potential for increasing screening use in Europe by better reaching the younger eligible individuals, those who have not been to the doctor recently and those at increased risk for CRC.
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Affiliation(s)
- Rafael Cardoso
- Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), 69120 Heidelberg, Germany;
- Medical Faculty Heidelberg, University of Heidelberg, 69120 Heidelberg, Germany; (F.G.); (T.H.)
- Correspondence: ; Tel.: +49-6221-42-3033
| | - Feng Guo
- Medical Faculty Heidelberg, University of Heidelberg, 69120 Heidelberg, Germany; (F.G.); (T.H.)
- Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany;
| | - Thomas Heisser
- Medical Faculty Heidelberg, University of Heidelberg, 69120 Heidelberg, Germany; (F.G.); (T.H.)
- Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany;
| | - Michael Hoffmeister
- Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany;
| | - Hermann Brenner
- Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), 69120 Heidelberg, Germany;
- Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany;
- German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany
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38
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Dominic OG, Chinchilli V, Wasserman E, Curry WJ, Kambic DM, Caicedo CH, Ramirez AG, Ochoa JA, Lengerich EJ. Impact of Social Support on Colorectal Cancer Screening among Adult Hispanics/Latinos: A Randomized Community-based Study in Central Pennsylvania. Cancer Prev Res (Phila) 2020; 13:531-542. [PMID: 32127350 DOI: 10.1158/1940-6207.capr-19-0333] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2019] [Revised: 10/22/2019] [Accepted: 02/27/2020] [Indexed: 11/16/2022]
Abstract
In the United States, the five-year survival rate of colorectal cancer for Latinos is lower than it is for White, non-Latinos. Differences in survival are due, in part, to Latinos being diagnosed at a later stage. An ethnic gap in the use of colorectal cancer screening contributes to the difference in survival. We developed, implemented, and evaluated a targeted colorectal cancer screening intervention to increase colorectal cancer screening uptake by sex, ethnicity, and geography. We measured actual colorectal cancer screening uptake in both arms as a method to determine completion rates. We used a randomized, community-based, participatory design to test the impact of social support (intervention) on completion of a provider-recommended, take-home fecal immunochemical test (FIT) kit screening test among average-risk, urban, and rural Pennsylvania Latino adults age 50 and older not currently adherent to national colorectal cancer screening guidelines (n = 264). Participants in each arm attended a community-based educational program offered at eight sites. Among the 264 participants, 154 (58%) returned a completed usable FIT kit screening test. A higher return rate was observed among participants in the social support arm (66.0%) compared with the control (47.2%). Participants in the social support arm were statistically significant 2.67 times as likely to return a completed FIT kit. Of these, 27 (17.5%) had a positive FIT kit screening test result. The results of this study suggest that social support is an effective method to increase colorectal cancer screening rates among Latinos. Future studies should examine dissemination and implementation of community-based strategies among Latinos that include social support.
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Affiliation(s)
- Oralia G Dominic
- Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania. .,Department of Biobehavioral Health, The Pennsylvania State University, College of Health and Human Development, University Park, Pennsylvania
| | - Vern Chinchilli
- Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania
| | - Emily Wasserman
- Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania
| | - William J Curry
- Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.,Department of Family and Community Medicine, The Pennsylvania State University College of Medicine, Hershey, Pennsylvania
| | - Daniel M Kambic
- Kambic Family Clinic, Steelton, Pennsylvania.,Pinnacle Health System, Harrisburg, Pennsylvania
| | | | - Amelie G Ramirez
- Institute for Health Promotion Research, Health Disparities Research, UT Health Science Center at San Antonio, San Antonio, Texas
| | - John A Ochoa
- Department of Spanish, Italian and Portuguese, College of Health and Human Development, The Pennsylvania State University, State College, Pennsylvania
| | - Eugene J Lengerich
- Department of Public Health Sciences, The Pennsylvania State University, College of Medicine, Hershey, Pennsylvania.,Department of Biobehavioral Health, The Pennsylvania State University, College of Health and Human Development, University Park, Pennsylvania.,Department of Family and Community Medicine, The Pennsylvania State University College of Medicine, Hershey, Pennsylvania.,Penn State Cancer Institute, The Pennsylvania State University, State College, Pennsylvania
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39
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Selby K, Levine EH, Doan C, Gies A, Brenner H, Quesenberry C, Lee JK, Corley DA. Effect of Sex, Age, and Positivity Threshold on Fecal Immunochemical Test Accuracy: A Systematic Review and Meta-analysis. Gastroenterology 2019; 157:1494-1505. [PMID: 31472152 PMCID: PMC6878177 DOI: 10.1053/j.gastro.2019.08.023] [Citation(s) in RCA: 65] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2019] [Revised: 07/18/2019] [Accepted: 08/09/2019] [Indexed: 02/06/2023]
Abstract
BACKGROUND & AIMS Quantitative fecal immunochemical tests (FITs) for hemoglobin are commonly used for colorectal cancer (CRC) screening. We aimed to quantify the change in CRC and advanced adenoma detection and number of positive test results at different positivity thresholds and by sex and age. METHODS We searched MEDLINE and EMBASE, selecting articles of FIT for CRC detection in asymptomatic adults undergoing screening. We calculated sensitivity and specificity, as well as detected number of cancers, advanced adenomas, and positive test results at positivity thresholds ≤10 μg hemoglobin/g feces, 10 to ≤20 μg/g, 20 to ≤30 μg/g, and >30 μg/g. We also analyzed results from stratified by patient sex, age, and reference standard. RESULTS Our meta-analysis comprised 46 studies with 2.4 million participants and 6478 detected cancers. Sensitivity for detection of CRC increased from 69% (95% confidence interval [CI], 63%-75%) at thresholds >10 μg/g and ≤20 μg/g to 80% (95% CI, 76%-83%) at thresholds ≤10 μg/g. At these threshold values, sensitivity for detection of advanced adenomas increased from 21% (95% CI, 18%-25%) to 31% (95% CI, 27%-35%), whereas specificity decreased from 94% (95% CI, 93%-96%) to 91% (95% CI, 89%-93%). In 3 studies stratified by sex, sensitivity of CRC detection was 77% in men (95% CI, 75%-79%) and 81% in women (95% CI, 60%-100%) (P = .68). In 3 studies stratified by age groups, sensitivity of CRC detection was 85% for ages 50-59 years (95% CI, 71%-99%) and 73% for ages 60-69 years (95% CI, 71%-75%) (P = .10). All studies with colonoscopy follow-up had similar sensitivity levels for detection of CRC to studies that analyzed 2-year registry follow-up data (74%; 95% CI, 68%-78% vs 75%; 95% CI, 73%-77%). CONCLUSIONS In a meta-analysis of studies that analyzed detection of CRC and advanced adenomas at different FIT positivity thresholds, we found the sensitivity and specificity of detection to vary with positive cutoff value. It might be possible to decrease positive threshold values for centers with sufficient follow-up colonoscopy resources. More research is needed to precisely establish FIT thresholds for each sex and age subgroup. PROTOCOL PROSPERO CRD42017068760.
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Affiliation(s)
- Kevin Selby
- Kaiser Permanente Division of Research, Oakland, California; Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland.
| | - Emma H Levine
- University of California-San Francisco, San Francisco, California
| | - Cecilia Doan
- Kaiser Permanente Division of Research, Oakland, California
| | - Anton Gies
- Division of Preventive Oncology, German Cancer Research Center and National Center for Tumor Diseases, Heidelberg, Germany; Medical Faculty Heidelberg, University of Heidelberg, Heidelberg, Germany
| | - Hermann Brenner
- Division of Preventive Oncology, German Cancer Research Center and National Center for Tumor Diseases, Heidelberg, Germany; Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany; German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany
| | | | - Jeffrey K Lee
- Kaiser Permanente Division of Research, Oakland, California
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40
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Hissong E, Pittman ME. Colorectal carcinoma screening: Established methods and emerging technology. Crit Rev Clin Lab Sci 2019; 57:22-36. [PMID: 31603697 DOI: 10.1080/10408363.2019.1670614] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/09/2023]
Abstract
Colorectal carcinoma screening programs have shown success in lowering both the incidence and mortality rate of colorectal carcinoma at a population level, in part because this carcinoma is relatively slow growing and has an identifiable premalignant lesion. Still, many patients do not undergo the recommended screening for colorectal carcinoma, and of those who do, a subset may be over- or under-diagnosed by the currently available testing methods. The primary purpose of this article is to review the data regarding currently available colorectal cancer screening modalities, which include fecal occult blood testing, direct colonic visualization, and noninvasive imaging techniques. In addition, readers will be introduced to a variety of biomarkers that may serve as stand-alone or adjunct tests in the future. Finally, there is a brief discussion of the current epidemiologic considerations that public health officials must address as they create population screening guidelines. The data we provide as laboratory physicians and scientists are critical to the construction of appropriate recommendations that ultimately decrease the burden of disease from colorectal carcinoma.
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Affiliation(s)
- Erika Hissong
- Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York City, NY, USA
| | - Meredith E Pittman
- Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York City, NY, USA
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41
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Wong G, Hope RL, Howard K, Chapman JR, Castells A, Roger SD, Bourke MJ, Macaskill P, Turner R, Williams G, Lim WH, Lok CE, Diekman F, Cross N, Sen S, Allen RDM, Chadban SJ, Pollock CA, Tong A, Teixeira-Pinto A, Yang JYH, Williams N, Au E, Kieu A, James L, Craig JC. Authors' Reply. J Am Soc Nephrol 2019; 30:2276-2277. [PMID: 31597717 DOI: 10.1681/asn.2019090889] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022] Open
Affiliation(s)
- Germaine Wong
- Faculty of Medicine and Health, Sydney School of Public Health, .,Centre for Transplant and Renal Research and
| | - Richard L Hope
- Department of Gastroenterology, Westmead Hospital, Westmead, Australia
| | - Kirsten Howard
- Faculty of Medicine and Health, Sydney School of Public Health
| | | | - Antoni Castells
- Gastroenterology Department, Hospital Clinic, Institute of Biomedical Research August Pi i Sunyer, Center for Biomedical Research in Network of Hepatic and Digestive Diseases, University of Barcelona, Barcelona, Spain
| | - Simon D Roger
- Department of Renal Medicine, Gosford Hospital, Gosford, Australia
| | - Michael J Bourke
- Department of Gastroenterology, Westmead Hospital, Westmead, Australia
| | - Petra Macaskill
- Faculty of Medicine and Health, Sydney School of Public Health
| | - Robin Turner
- Faculty of Medicine and Health, Sydney School of Public Health.,Biostatistics Unit, Dunedin School of Medicine, University of Otago, Christchurch, New Zealand
| | | | - Wai H Lim
- Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia
| | - Charmaine E Lok
- Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Fritz Diekman
- Department of Nephrology and Kidney Transplantation, Hospital Clínic, Barcelona, Spain
| | - Nicholas Cross
- Department of Nephrology and Kidney Transplantation, Christchurch Hospital and Otago University, Christchurch, New Zealand
| | - Shaundeep Sen
- Department of Renal Medicine, Concord Repatriation General Hospital, Concord, Australia
| | - Richard D M Allen
- Department of Renal Medicine, Royal Prince Alfred Hospital, Camperdown, Sydney, Australia.,Charles Perkins Centre, and
| | - Steven J Chadban
- Department of Renal Medicine, Royal Prince Alfred Hospital, Camperdown, Sydney, Australia.,Charles Perkins Centre, and
| | - Carol A Pollock
- Department of Medicine, Northern Clinical School, Kolling Institute of Medical Research, St. Leonards, Australia
| | - Allison Tong
- Faculty of Medicine and Health, Sydney School of Public Health
| | | | - Jean Y H Yang
- School of Mathematics and Statistics, The University of Sydney, Sydney, Australia
| | | | - Eric Au
- Faculty of Medicine and Health, Sydney School of Public Health,
| | - Anh Kieu
- Faculty of Medicine and Health, Sydney School of Public Health
| | - Laura James
- Faculty of Medicine and Health, Sydney School of Public Health
| | - Jonathan C Craig
- College of Medicine and Public Health, Flinders University, Adelaide, Australia
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Buskermolen M, Cenin DR, Helsingen LM, Guyatt G, Vandvik PO, Haug U, Bretthauer M, Lansdorp-Vogelaar I. Colorectal cancer screening with faecal immunochemical testing, sigmoidoscopy or colonoscopy: a microsimulation modelling study. BMJ 2019; 367:l5383. [PMID: 31578177 PMCID: PMC6774435 DOI: 10.1136/bmj.l5383] [Citation(s) in RCA: 76] [Impact Index Per Article: 12.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/14/2019] [Indexed: 12/24/2022]
Abstract
OBJECTIVE To estimate benefits and harms of different colorectal cancer screening strategies, stratified by (baseline) 15-year colorectal cancer risk. DESIGN Microsimulation modelling study using MIcrosimulation SCreening ANalysis-Colon (MISCAN-Colon). SETTING A parallel guideline committee (BMJ Rapid Recommendations) defined the time frame and screening interventions, including selection of outcome measures. POPULATION Norwegian men and women aged 50-79 years with varying 15-year colorectal cancer risk (1-7%). COMPARISONS Four screening strategies were compared with no screening: biennial or annual faecal immunochemical test (FIT) or single sigmoidoscopy or colonoscopy at 100% adherence. MAIN OUTCOME MEASURES Colorectal cancer mortality and incidence, burdens, and harms over 15 years of follow-up. The certainty of the evidence was assessed using the GRADE approach. RESULTS Over 15 years of follow-up, screening individuals aged 50-79 at 3% risk of colorectal cancer with annual FIT or single colonoscopy reduced colorectal cancer mortality by 6 per 1000 individuals. Single sigmoidoscopy and biennial FIT reduced it by 5 per 1000 individuals. Colonoscopy, sigmoidoscopy, and annual FIT reduced colorectal cancer incidence by 10, 8, and 4 per 1000 individuals, respectively. The estimated incidence reduction for biennial FIT was 1 per 1000 individuals. Serious harms were estimated to be between 3 per 1000 (biennial FIT) and 5 per 1000 individuals (colonoscopy); harms increased with older age. The absolute benefits of screening increased with increasing colorectal cancer risk, while harms were less affected by baseline risk. Results were sensitive to the setting defined by the guideline panel. Because of uncertainty associated with modelling assumptions, we applied a GRADE rating of low certainty evidence to all estimates. CONCLUSIONS Over a 15 year period, all screening strategies may reduce colorectal cancer mortality to a similar extent. Colonoscopy and sigmoidoscopy may also reduce colorectal cancer incidence, while FIT shows a smaller incidence reduction. Harms are rare and of similar magnitude for all screening strategies.
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Affiliation(s)
- Maaike Buskermolen
- Erasmus MC, University Medical Center Rotterdam, Department of Public Health, Rotterdam, the Netherlands
| | - Dayna R Cenin
- Erasmus MC, University Medical Center Rotterdam, Department of Public Health, Rotterdam, the Netherlands
- Centre for Health Services Research, School of Population and Global Health, The University of Western Australia, Perth, Western Australia, Australia
| | - Lise M Helsingen
- Clinical Effectiveness Research Group, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
- Clinical Effecitveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway
- Frontier Science Foundation, Boston, MA, USA
| | - Gordon Guyatt
- Department of Health Research Methods, Evidence and Impact, McMaster University, ON, Canada
| | - Per Olav Vandvik
- Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway
| | - Ulrike Haug
- Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
- Faculty of Human and Health Sciences, University of Bremen, Bremen, Germany
| | - Michael Bretthauer
- Clinical Effectiveness Research Group, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
- Clinical Effecitveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway
- Frontier Science Foundation, Boston, MA, USA
| | - Iris Lansdorp-Vogelaar
- Erasmus MC, University Medical Center Rotterdam, Department of Public Health, Rotterdam, the Netherlands
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Bharti B, May FFP, Nodora J, Martínez ME, Moyano K, Davis SL, Ramers CB, Garcia-Bigley F, O'Connell S, Ronan K, Barajas M, Gordon S, Diaz G, Ceja E, Powers M, Arredondo EM, Gupta S. Diagnostic colonoscopy completion after abnormal fecal immunochemical testing and quality of tests used at 8 Federally Qualified Health Centers in Southern California: Opportunities for improving screening outcomes. Cancer 2019; 125:4203-4209. [PMID: 31479529 DOI: 10.1002/cncr.32440] [Citation(s) in RCA: 32] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2019] [Revised: 04/22/2019] [Accepted: 04/24/2019] [Indexed: 12/13/2022]
Abstract
BACKGROUND The effectiveness of colorectal cancer screening with fecal immunochemical tests (FITs) of stool blood depends on high rates of colonoscopy follow-up for abnormal FITs and the use of high-quality tests. This study characterized colonoscopy referral and completion among patients with abnormal FITs and the types of FITs implemented in a sample of Southern California Federally Qualified Health Centers (FQHCs). METHODS FQHCs in San Diego, Imperial, and Los Angeles Counties were invited to define a cohort of ≥150 consecutive patients with abnormal FITs in 2015-2016 and to provide data on sex, insurance status, diagnostic colonoscopy referrals and completion within 6 months of abnormal FITs, and the types (brands) of FITs implemented. The primary outcomes were the proportions with colonoscopy referrals and completion for all patients at each FQHC and in aggregate. RESULTS Eight FQHCs provided data for 1229 patients with abnormal FITs; 46% were male, and 20% were uninsured. Among patients with abnormal FITs, 89% (1091 of 1229; 95% confidence interval [CI], 0.87-0.91) had a colonoscopy referral, and 44% (539 of 1229; 95% CI, 0.41-0.47) had colonoscopy completion. Across FQHCs, the range for colonoscopy referral was 73% to 96%, and the range for completion was 18% to 57%. Six of the 8 FQHCs (75%) reported FIT brands with limited data to support their effectiveness. CONCLUSIONS In a sample of Southern California FQHCs, diagnostic colonoscopy completion after abnormal FITs was substantially below the nationally recommended benchmark to achieve 80% completion, and the use of FIT brands with limited data to support their effectiveness was high. These findings suggest a need for policies and multilevel interventions to promote diagnostic colonoscopy among individuals with abnormal FITs and the use of higher quality FITs.
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Affiliation(s)
- Balambal Bharti
- University of California San Diego, La Jolla, California.,Moores Cancer Center, University of California San Diego, La Jolla, California
| | - Folasade Fola Popoola May
- Jonsson Comprehensive Cancer Center and Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.,Division of Gastroenterology, Department of Medicine, VA Greater Los Angeles Healthcare System, Los Angeles, California
| | - Jesse Nodora
- University of California San Diego, La Jolla, California.,Moores Cancer Center, University of California San Diego, La Jolla, California.,Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California
| | - María Elena Martínez
- University of California San Diego, La Jolla, California.,Moores Cancer Center, University of California San Diego, La Jolla, California.,Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California
| | | | | | - Christian B Ramers
- University of California San Diego, La Jolla, California.,Family Health Centers of San Diego, San Diego, California
| | | | | | | | | | - Sheree Gordon
- To Help Everyone Health and Wellness Centers, Los Angeles, California
| | - Giselle Diaz
- Northeast Valley Health Center, Los Angeles, California
| | - Evelyn Ceja
- South Central Family Health Center, Los Angeles, California
| | | | | | - Samir Gupta
- University of California San Diego, La Jolla, California.,Moores Cancer Center, University of California San Diego, La Jolla, California.,VA San Diego Healthcare System, San Diego, California
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Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples. Clin Gastroenterol Hepatol 2019; 17:1822-1828. [PMID: 30503967 PMCID: PMC6714971 DOI: 10.1016/j.cgh.2018.11.050] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2018] [Revised: 11/19/2018] [Accepted: 11/25/2018] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS The fecal immunochemical test (FIT) is an alternative to colonoscopy and can increase overall screening for colorectal cancer (CRC). However, little is known about the frequency of and reasons for mishandled FIT samples. METHODS We performed a prospective study, nested within a randomized controlled trial of patients, recruited from December 2015 through August 2017, who were not up to date with colorectal cancer screening (50-75 years old). The patients were randomly assigned to usual care or outreach groups that received a mailed FIT with low literacy level instructions or a reminder call, or both. We examined frequency of and reasons for mishandled FIT samples, including absence of collection date; time from collection to laboratory receipt of more than 14 days; or mishandling of stool, buffer, or cap. The outcomes were the frequency of mishandled FIT samples, effects of outreach on mishandling, and positive results from the FIT among proper and mishandled samples. RESULTS FIT samples were returned from 1871 patients assigned to usual care and 3045 who received the low literacy level instructions and a reminder call. In total, 19.8% of samples were mishandled; most of these (93.7%) had not labeled the date of stool collection but were still processed. Of the received samples, 1.2% of were not processed because the time from patient collection to laboratory receipt was more than 14 days. Outreach was associated with a lower proportion of mishandled samples (16.5% vs 25.0% for usual care; P < .0001). The proportion of mishandled samples was lowest among patients who received the low literacy level instruction and a reminder call (12.8%, P < .0001). There was no significant difference in proportions of positive results between properly processed samples (7.5%) and improperly processed samples (6.2%) (P = .14). CONCLUSION In a prospective study of patients who were not up to date with colorectal cancer screening, we found that almost 20% of FIT samples were mishandled, with most patients missing the stool collection date. Patient outreach was associated with a lower proportion of mishandled samples, but there was no difference in proportions of positive results between properly and improperly handled samples. Our findings indicate that routine processing of undated FIT samples is associated with similar rates of positive results. There are limited data on test characteristics for FIT samples beyond the 14 days of stool acquisition. The inclusion of low literacy level instructions with reminder calls was associated with improved patient handling of the FIT sample. ClincialTrials.gov no: NCT02613260.
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45
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Onyoh EF, Hsu WF, Chang LC, Lee YC, Wu MS, Chiu HM. The Rise of Colorectal Cancer in Asia: Epidemiology, Screening, and Management. Curr Gastroenterol Rep 2019; 21:36. [PMID: 31289917 DOI: 10.1007/s11894-019-0703-8] [Citation(s) in RCA: 111] [Impact Index Per Article: 18.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/28/2023]
Abstract
PURPOSE OF REVIEW Colorectal cancer (CRC) remains the third most commonly diagnosed cancer globally, and its incidence and mortality rates have been on the rise in Asia. In this paper, we summarize the recent trends and screening challenges of CRC in this region. RECENT FINDINGS In 2018, Asia had the highest proportions of both incident (51.8%) and mortality (52.4%) CRC cases (all genders and ages) per 100,000 population in the world. In addition, there has been a rising trend of this disease across Asia with some regional geographic variations. This rise in CRC can be attributed to westernized dietary lifestyle, increasing population aging, smoking, physical inactivity, and other risk factors. In curbing the rising trend, Japan, South Korea, Singapore, and Taiwan have launched nationwide population-based screening programs. CRC screening across this region has been found to be effective and cost-effective compared with no screening at all. The emergence of new therapies has caused a reduction in case fatality; however, these new options have had a limited impact on cure rates and long-term survival due to the great disparity in treatment capacity/resources and screening infrastructures among Asian countries with different degrees of economic development. CRC is still rising in Asia, and implementation of screening is necessary for moderate- to high-incidence countries and construction of treatment capacity is the priority task in low-incidence and low-income countries. Unless countries in Asia implement CRC screening, the incidence and mortality rates of this disease will continue to rise especially with the rapidly rising population growth, economic development, westernized lifestyle, and increasing aging.
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Affiliation(s)
- Elias F Onyoh
- Institute of Epidemiology and Preventive Medicine, National Taiwan University, Taipei, Taiwan
- AIDS Care and Prevention Program, Cameroon Baptist Convention Health Services, Bamenda, Cameroon
- Taiwanese Colorectal Cancer Screening Program, Taipei, Taiwan
| | - Wen-Feng Hsu
- Taiwanese Colorectal Cancer Screening Program, Taipei, Taiwan
- Department of Internal Medicine, National Taiwan University Hospital, No. 7 Chung-Shan South Road, Taipei, Taiwan
| | - Li-Chun Chang
- Department of Internal Medicine, National Taiwan University Hospital, No. 7 Chung-Shan South Road, Taipei, Taiwan
| | - Yi-Chia Lee
- Taiwanese Colorectal Cancer Screening Program, Taipei, Taiwan
- Department of Internal Medicine, National Taiwan University Hospital, No. 7 Chung-Shan South Road, Taipei, Taiwan
| | - Ming-Shiang Wu
- Department of Internal Medicine, National Taiwan University Hospital, No. 7 Chung-Shan South Road, Taipei, Taiwan
| | - Han-Mo Chiu
- Taiwanese Colorectal Cancer Screening Program, Taipei, Taiwan.
- Department of Internal Medicine, College of Medicine, National Taiwan University Hospital, No. 7 Chung-Shan South Road, Taipei, Taiwan.
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46
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Beshara A, Ahoroni M, Comanester D, Vilkin A, Boltin D, Dotan I, Niv Y, Cohen AD, Levi Z. Association between time to colonoscopy after a positive guaiac fecal test result and risk of colorectal cancer and advanced stage disease at diagnosis. Int J Cancer 2019; 146:1532-1540. [DOI: 10.1002/ijc.32497] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2019] [Accepted: 05/09/2019] [Indexed: 12/22/2022]
Affiliation(s)
- Amani Beshara
- Division of GastroenterologyRabin Medical Center Petah Tikva Israel
- Sackler School of Medicine, Tel Aviv University Tel Aviv Israel
| | - Maya Ahoroni
- Division of GastroenterologyRabin Medical Center Petah Tikva Israel
| | | | - Alex Vilkin
- Division of GastroenterologyRabin Medical Center Petah Tikva Israel
| | - Doron Boltin
- Division of GastroenterologyRabin Medical Center Petah Tikva Israel
- Sackler School of Medicine, Tel Aviv University Tel Aviv Israel
| | - Iris Dotan
- Division of GastroenterologyRabin Medical Center Petah Tikva Israel
- Sackler School of Medicine, Tel Aviv University Tel Aviv Israel
| | - Yaron Niv
- Division of GastroenterologyRabin Medical Center Petah Tikva Israel
- Sackler School of Medicine, Tel Aviv University Tel Aviv Israel
| | - Arnon D. Cohen
- Department of Quality Measurements and ResearchChief Physician's Office, Clalit Health Services Tel Aviv Israel
- Siaal Research Center for Family Medicine and Primary Care, Faculty of Health SciencesBen‐Gurion University of the Negev Beer‐Sheva Israel
| | - Zohar Levi
- Division of GastroenterologyRabin Medical Center Petah Tikva Israel
- Sackler School of Medicine, Tel Aviv University Tel Aviv Israel
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47
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Katz M, Silverstein N, Coll P, Sullivan G, Mortensen EM, Sachs A, Gross JB, Girard E, Liang J, Ristau BT, Stevenson C, Smith PP, Shames BD, Millea R, Ali I, Poulos CM, Ramaraj AB, Otukoya AO, Nolan J, Wahla Z, Hardy C, Al-Naggar I, Bliss LA, McFadden DW. Surgical care of the geriatric patient. Curr Probl Surg 2019; 56:260-329. [DOI: 10.1067/j.cpsurg.2019.03.003] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2018] [Accepted: 03/13/2019] [Indexed: 12/15/2022]
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Malagón M, Ramió-Pujol S, Serrano M, Serra-Pagès M, Amoedo J, Oliver L, Bahí A, Mas-de-Xaxars T, Torrealba L, Gilabert P, Miquel-Cusachs JO, García-Nimo L, Saló J, Guardiola J, Piñol V, Cubiella J, Castells A, Aldeguer X, Garcia-Gil J. Reduction of faecal immunochemical test false-positive results using a signature based on faecal bacterial markers. Aliment Pharmacol Ther 2019; 49:1410-1420. [PMID: 31025420 DOI: 10.1111/apt.15251] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/09/2018] [Revised: 05/22/2018] [Accepted: 03/04/2019] [Indexed: 12/11/2022]
Abstract
BACKGROUND Colorectal cancer is the second commonest cause of cancer mortality. Some countries are implementing colorectal cancer screening to detect lesions at an early stage using non-invasive tools like the faecal immunochemical test. Despite affordability, this test shows a low sensitivity for precancerous lesions and a low positive predictive value for colorectal cancer, resulting in a high false-positive rate. AIM To develop a new, non-invasive colorectal cancer screening tool based on bacterial faecal biomarkers, which in combination with the faecal immunochemical test, could allow a reduction in the false-positive rate. This tool is called risk assessment of intestinal disease for colorectal cancer (RAID-CRC). METHODS We performed both the faecal immunochemical test and the bacterial markers analysis (RAID-CRC test) in stool samples from individuals with normal colonoscopy (167), non-advanced adenomas (88), advanced adenomas (30) and colorectal cancer (48). All the participants showed colorectal cancer-associated symptoms. RESULTS Performance of the faecal immunochemical test for advanced neoplasia (ie advanced adenoma and colorectal cancer) was determined by using the cut-off value established in Catalonia (20 µg haemoglobin/g of faeces) for a population-based screening approach. Sensitivity and specificity values of 83% and 80%, respectively, and positive and negative predictive values of 56% and 94%, respectively, were obtained. When both the immunological and the biological analysis were combined, the corresponding values were 80% and 90% for sensitivity and specificity, respectively, and 70% and 94% for positive and negative predictive values, respectively, resulting in a 50% reduction of the false-positive rate. CONCLUSIONS RAID-CRC test allows a substantial reduction in the faecal immunochemical test false-positive results (50%) in a symptomatic population. Further validation is indicated in a colorectal cancer-screening scenario.
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Affiliation(s)
- Marta Malagón
- GoodGut SL, Girona, Spain.,Institut d'Investigació Biomèdica de Girona-IDIBGI, Salt, Spain.,Universitat de Girona, Girona, Spain
| | | | | | | | - Joan Amoedo
- GoodGut SL, Girona, Spain.,Universitat de Girona, Girona, Spain
| | | | - Anna Bahí
- Institut d'Investigació Biomèdica de Girona-IDIBGI, Salt, Spain
| | | | | | - Pau Gilabert
- Hospital Universitari de Bellvitge-IDIBELL, l'Hospitalet de Llobregat, Spain
| | | | - Laura García-Nimo
- Clinical Analysis Department, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Sanitaria Galicia Sur, Ourense, Spain
| | - Joan Saló
- Consorci Hospitalari de Vic, Vic, Spain
| | - Jordi Guardiola
- Hospital Universitari de Bellvitge-IDIBELL, l'Hospitalet de Llobregat, Spain
| | - Virginia Piñol
- Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain
| | - Joaquin Cubiella
- Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Sanitaria Galicia Sur, CIBERehd, Ourense, Spain
| | - Antoni Castells
- Gastroenterology Department, Hospital Clínic, University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
| | - Xavier Aldeguer
- GoodGut SL, Girona, Spain.,Institut d'Investigació Biomèdica de Girona-IDIBGI, Salt, Spain.,Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain
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Diagnostic Accuracy of FOBT and Colorectal Cancer Genetic Testing: A Systematic Review & Meta-Analysis. Ann Glob Health 2019; 85. [PMID: 31099505 PMCID: PMC6634323 DOI: 10.5334/aogh.2466] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022] Open
Abstract
Introduction: Colorectal cancer (CRC) is the second leading cause of cancer related death in the world after lung cancer. Early detection of CRC leads to improvement in cancer survival rate. In recent years, efforts have been made to discover a non-invasive screening marker of higher sensitivity and specificity. Fecal occult blood testing (FOBT) and genetic testing become alternative modalities to screen CRC in the population other than colonoscopy. The aim of this systematic review and meta-analysis is to determine the diagnostic accuracy, sensitivity and specificity of FOBT and genetic testing as screening tools in colorectal cancer. Methods: A literature search of PubMed, ScienceDirect, and Scopus was carried out. The search strategy was restricted to human subjects and studies are published in English. Data on sensitivity and specificity were extracted and pooled. Heterogeneity was assumed at significance level of p < 0.10 and was tested by chi squared. Degree of heterogeneity was quantified using the I2 statistic, and values of less than 25% is considered as homogenous. All analyses were performed using the software Meta-Disc. Results: A total of eleven studies were suitable for data synthesis and analysis. Five studies were analyzed for the accuracy of genetic testing, the pooled estimate for sensitivity and specificity were 71% (95% CI: 66, 75%) and 95% (95% CI: 93, 97%) respectively. Another group of studies which had been evaluated for the accuracy of FOBT, the pooled sensitivity was 31% (95% CI: 25, 38%) while the pooled specificity was 87% (95% CI: 86, 89%). Conclusions: FOBTs is recommended to use as population-based screening tools for colorectal cancer while genetic testing should be focusing on patients with moderate and high risk individuals.
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Imperiale TF, Gruber RN, Stump TE, Emmett TW, Monahan PO. Performance Characteristics of Fecal Immunochemical Tests for Colorectal Cancer and Advanced Adenomatous Polyps: A Systematic Review and Meta-analysis. Ann Intern Med 2019; 170:319-329. [PMID: 30802902 DOI: 10.7326/m18-2390] [Citation(s) in RCA: 157] [Impact Index Per Article: 26.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Studies report inconsistent performance of fecal immunochemical tests (FITs) for colorectal cancer (CRC) and advanced adenomas. PURPOSE To summarize performance characteristics of FITs for CRC and advanced adenomas in average-risk persons undergoing screening colonoscopy (reference standard) and to identify factors affecting these characteristics. DATA SOURCES Ovid MEDLINE, PubMed, Embase, and the Cochrane Library from inception through October 2018; reference lists of studies and reviews. STUDY SELECTION Two reviewers independently screened records to identify published English-language prospective or retrospective observational studies that evaluated FIT sensitivity and specificity for colonoscopic findings in asymptomatic, average-risk adults. DATA EXTRACTION Two authors independently extracted data and evaluated study quality. DATA SYNTHESIS Thirty-one studies (120 255 participants; 18 FITs) were included; all were judged to have low to moderate risk of bias. Performance characteristics depended on the threshold for a positive result. A threshold of 10 µg/g resulted in sensitivity of 0.91 (95% CI, 0.84 to 0.95) and a negative likelihood ratio of 0.10 (CI, 0.06 to 0.19) for CRC, whereas a threshold of greater than 20 µg/g resulted in specificity of 0.95 (CI, 0.94 to 0.96) and a positive likelihood ratio of 15.49 (CI, 9.82 to 22.39). For advanced adenomas, sensitivity was 0.40 (CI, 0.33 to 0.47) and the negative likelihood ratio was 0.67 (CI, 0.57 to 0.78) at 10 µg/g, and specificity was 0.95 (CI, 0.94 to 0.96) and the positive likelihood ratio was 5.86 (CI, 3.77 to 8.97) at greater than 20 µg/g. Studies had low to high heterogeneity, depending on the threshold. Although several FITs had adequate performance, sensitivity and specificity for CRC for 1 qualitative FIT were 0.90 and 0.91, respectively, at its single threshold of 10 µg/g; positive and negative likelihood ratios were 10.13 and 0.11, respectively. Comparison of 3 FITs at 3 thresholds was inconclusive: CIs overlapped, and the comparisons were across rather than within studies. LIMITATIONS Only English-language studies were included. Incomplete reporting limited quality assessment of some evidence. Performance characteristics are for 1-time rather than serial testing. CONCLUSION Single-application FITs have moderate to high sensitivity and specificity for CRC, depending on the positivity threshold. Sensitivity of 1-time testing for advanced adenomas is low, regardless of the threshold. PRIMARY FUNDING SOURCE Department of Medicine, Indiana University School of Medicine.
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Affiliation(s)
- Thomas F Imperiale
- Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and Regenstrief Institute, Indianapolis, Indiana (T.F.I.)
| | | | - Timothy E Stump
- Indiana University School of Medicine, Indianapolis, Indiana (T.E.S., P.O.M.)
| | | | - Patrick O Monahan
- Indiana University School of Medicine, Indianapolis, Indiana (T.E.S., P.O.M.)
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