Diagnostic utility of microRNA profiles in cavitatory and non-cavitatory pulmonary tuberculosis: Research protocol

doi:10.5493/wjem.v15.i1.97460

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World Journal of Experimental Medicine

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Exp Med. Mar 20, 2025; 15(1): 97460
Published online Mar 20, 2025. doi: 10.5493/wjem.v15.i1.97460

Diagnostic utility of microRNA profiles in cavitatory and non-cavitatory pulmonary tuberculosis: Research protocol

Swathy Moorthy, Emmanuel Bhaskar, Shivakumar Singh, Santhi Silambanan

Swathy Moorthy, Emmanuel Bhaskar, Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, Chennai 600116, Tamil Nādu, India

Shivakumar Singh, Department of Medicine, Railway Hospital, Perumbur, Chennai, Chennai 600023, Tamil Nādu, India

Santhi Silambanan, Department of Biochemistry, Sri Ramachandra Institute of Higher Education and Research, Chennai 600116, Tamil Nādu, India

Author contributions: Moorthy S, Bhaskar E, Singh S, and Silambanan S designed the research study; Moorthy S, Bhaskar E, and Santhi S performed the research; Moorthy S and Santhi S contributed new reagents and analytic tools; Moorthy S, Bhaskar E, Singh S, and Silambanan S analyzed the data and wrote the manuscript. All authors have read and approved the final manuscript.

Institutional review board statement: The Institutional Ethics Committee has approved the study (IEC number IEC/21/JUN/163/43).

Clinical trial registration statement: The study is registered with Indian Council of Medical Research, India, CTRI/2023/08/056740 (https://ctri.nic.in/Clinicaltrials/Login.php).

Informed consent statement: Written informed consent will be obtained from all participants.

Conflict-of-interest statement: The authors declare that there were no conflicts of interest.

Data sharing statement: All the required data are provided in the article itself.

CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.

Corresponding author: Santhi Silambanan, DNB, MD, Professor, Department of Biochemistry, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116, Tamil Nādu, India. santhisilambanan@sriramachandra.edu.in

Received: May 30, 2024
Revised: October 31, 2024
Accepted: December 9, 2024
Published online: March 20, 2025
Processing time: 209 Days and 11.2 Hours

Abstract

BACKGROUND

Tuberculosis (TB) is a common infection causing huge morbidity and mortality to mankind. The analytical methods used in diagnosing TB are not sensitive in paucibacillary infections and also require trained technical personnel. MicroRNAs are stable in serum and other body fluids, and hold great potential in the diagnosis of TB.

AIM

To analyze the dysregulated microRNA profiles among patients with cavitatory and non-cavitatory pulmonary TB.

METHODS

The prospective study will be conducted in a tertiary care center in India. Adult patients with newly diagnosed pulmonary TB will be included. There will be two groups: Patients with sputum positive pulmonary TB with cavity and without cavity (group1), and apparently healthy individuals (group 2). The participants will undergo sputum examination, Xpert Mycobacterium TB complex/resistance to rifampin (Mtb/RIF) assay, chest X-ray, and blood investigations and serum microRNA detection. Ethics approval has been obtained. Written informed consent will be obtained. Appropriate statistical analyses will be used.

RESULTS

MicroRNAs will be correlated with sputum positivity, Xpert Mtb/RIF assay, radiological involvement, inflammatory markers, and course of the disease among cases and controls.

CONCLUSION

MicroRNAs could serve as potential diagnostic biomarkers in diagnostically challenging TB patients.

Keywords: Imaging; Inflammatory marker; MicroRNA; Molecular diagnosis; Pulmonary tuberculosis; CBNAAT

Core Tip: Tuberculosis (TB) is a multisystem infectious disease. The route of entry of Mycobacterium tuberculosis is via the respiratory system, hence the commonest presentation is lung TB. It has various presentations from subtle lesions to cavitation in the lung. If not treated in time, it spreads to various organs which can increase morbidity and mortality. Current diagnostic tools lack sensitivity and are time-consuming. Identification of the microRNA profiles in TB could help in devising point-of-care testing which may be used at bed side or physician consulting rooms.