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

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.