Observational Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Apr 15, 2024; 16(4): 1361-1373
Published online Apr 15, 2024. doi: 10.4251/wjgo.v16.i4.1361
Effectiveness of fecal DNA syndecan-2 methylation testing for detection of colorectal cancer in a high-risk Chinese population
Wen-Feng Luo, Yu-Ting Jiao, Xiao-Ling Lin, Ying Zhao, Sheng-Bo Wang, Jian Shen, Jie Deng, Yu-Feng Ye, Ze-Ping Han, Fang-Mei Xie, Jin-Hua He, Yu Wan
Wen-Feng Luo, Xiao-Ling Lin, Ying Zhao, Jian Shen, Ze-Ping Han, Fang-Mei Xie, Jin-Hua He, Central Laboratory of Panyu Central Hospital, Guangzhou Panyu Central Hospital, Guangzhou 511400, Guangdong Province, China
Yu-Ting Jiao, South China Normal University-Panyu Central Hospital Joint Laboratory of Translational Medical Research, Guangzhou Panyu Central Hospital, Guangzhou 511400, Guangdong Province, China
Sheng-Bo Wang, Yu Wan, Digestive Disease Center, Guangzhou Panyu Central Hospital, Guangzhou 511400, Guangdong Province, China
Jie Deng, Shunde Vocational and Technical College, Foshan 528300, Guangdong Province, China
Yu-Feng Ye, Medical Imaging Institute of Panyu, Guangzhou Panyu Central Hospital, Guangzhou 511400, Guangdong Province, China
Co-first authors: Wen-Feng Luo and Yu-Ting Jiao.
Co-corresponding authors: Wen-Feng Luo and Yu Wan.
Author contributions: Luo WF and Jiao YT contributed equally to this work; Luo WF and Wan Y were co-corresponding authors; Luo WF, Jiao YT, and Wan Y contributed to conceptualization, visualization, initial draft writing, funding acquisition, review and editing; Luo WF, Jiao YT, Wang SB, and Deng J proposed and designed the study; Lin XL, Shen J, and Xie FM performed analyses; Zhao Y, Han ZP, and Han ZP wrote the initial draft; Jiao YT, Ye YF, He JH, and Wan Y revised the manuscript; and all authors read and approved the final manuscript.
Supported by the Science and Technology Program of Panyu Central Hospital, No. PY-2023-003; the Science and Technology Program of Panyu, No. 2020-Z04-054; the Science and Technology Project of the Guangzhou Health Commission, No. 20211A011114; the Science and Technology Program of Guangzhou, No. 202002020023; the General University Youth Innovative Talent Project of Guangdong Province, No. 2022KQNCX281; the Guangdong Provincial Key Field Special Project for Ordinary Colleges and Universities, No. 2023ZDZX2097; and the Foshan Engineering Technology Research Center for Prepared Food Processing and Quality Evaluation, No. 2022-KJZX113.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Panyu Central Hospital in China (Approval No. [2019]62).
Informed consent statement: The informed consent was obtained from all study participants.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Wen-Feng Luo, MS, PhD, Assistant Professor, Doctor, Central Laboratory of Panyu Central Hospital, Guangzhou Panyu Central Hospital, No. 8 East Fuyu Road, Qiaonan Street, Panyu District, Guangzhou 511400, Guangdong Province, China. luowenfeng163@163.com
Received: December 21, 2023
Peer-review started: December 21, 2023
First decision: December 28, 2023
Revised: January 12, 2024
Accepted: February 7, 2024
Article in press: February 7, 2024
Published online: April 15, 2024
Processing time: 112 Days and 1.9 Hours
Abstract
BACKGROUND

Colorectal cancer (CRC) is among the most prevalent and life-threatening malignancies worldwide. Syndecan-2 methylation (mSDC2) testing has emerged as a widely used biomarker for early detection of CRC in stool and serum samples. Cancer (CRC) is among the most prevalent and life-threatening malignancies worldwide. mSDC2 testing has emerged as a widely used biomarker for early detection of CRC in stool and serum samples.

AIM

To validate the effectiveness of fecal DNA mSDC2 testing in the detection of CRC among a high-risk Chinese population to provide evidence-based data for the development of diagnostic and/or screening guidelines for CRC in China.

METHODS

A high-risk Chinese cohort consisting of 1130 individuals aged 40-79 years was selected for evaluation via fecal mSDC2 testing. Sensitivity and specificity for CRC, advanced adenoma (AA) and advanced colorectal neoplasia (ACN) were determined. High-risk factors for the incidence of colorectal lesions were determined and a logistic regression model was constructed to reflect the efficacy of the test.

RESULTS

A total of 1035 high-risk individuals were included in this study according to established criteria. Among them, 16 suffered from CRC (1.55%), 65 from AA (6.28%) and 189 from non-AAs (18.26%); 150 patients were diagnosed with polyps (14.49%). Diagnoses were established based upon colonoscopic and pathological examinations. Sensitivities of the mSDC2 test for CRC and AA were 87.50% and 40.00%, respectively; specificities were 95.61% for other groups. Positive predictive values of the mSDC2 test for CRC, AA and ACN were 16.09%, 29.89% and 45.98%, respectively; the negative predictive value for CRC was 99.79%. After adjusting for other high-risk covariates, mSDC2 test positivity was found to be a significant risk factor for the occurrence of ACN (P < 0.001).

CONCLUSION

Our findings confirmed that offering fecal mSDC2 testing and colonoscopy in combination for CRC screening is effective for earlier detection of malignant colorectal lesions in a high-risk Chinese population.

Keywords: Colorectal cancer; Syndecan-2; DNA methylation; Chinese population

Core Tip: A high-risk Chinese cohort composed of 1130 individuals 40-79 years of age was selected for evaluation using the fecal syndecan-2 methylation (mSDC2) test. Sensitivity and specificity to colorectal cancer (CRC), advanced adenoma and advanced colorectal neoplasia were quantified. High-risk factors for the incidence of colorectal lesions were analyzed; a logistic regression model was subsequently constructed to better reflect the efficacy of fecal mSDC2 testing. The results of this CRC screening study revealed that offering patients a combination of fecal mSDC2 testing and colonoscopy is ideal for facilitating early detection of CRC among a high-risk Chinese population.