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Study identifier: NCT06439810 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA

Condition: Tuberculosis, Pleural  ·  Sponsor: Chinese University of Hong Kong

PhaseN/A
Planned participants400
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Tuberculosis (TB) is one of the major global health threats and is the second leading infectious cause of death after COVID-19 in 2022. Extrapulmonary TB (EPTB), amongst which tuberculous pleuritis (TBP) is one of the most common subtypes, poses additional obstacles to global TB control due to its difficulty in diagnosis. The diagnosis of TBP is challenging. The ideal way of confirming TBP is by direct detection of TB bacteria or its specific component in the pleural space. However, the performance of available diagnostic tests is far from satisfactory, and no single test can achieve multiple diagnostic goals simultaneously, including high detection sensitivity, high specificity to exclude other diseases, low invasiveness and detection of drug resistance. The inability to diagnose TBP early leads to unnecessary invasive pleural procedures and delayed curative treatment. There is a pressing need for a better diagnostic test to diagnose TBP confidently. When TB bacteria die or break down, the DNA materials shed into the pleural space, forming Mycobacterium tuberculosis cell-free DNA (MTB cfDNA), which may aid in diagnosing TBP. However, only limited literature explored this aspect, and the sensitivity rates reported were still suboptimal due to the scarcity of DNA materials in the pleural fluid. Based on a small patient cohort, our group has recently developed a new laboratory assay measuring MTB cfDNA to overcome this problem, with a superior diagnostic performance to conven…

This description comes directly from the study's public registry record.

Talk to the study team

Ka Pang Chan, MBChB  ·  35052211  ·  chankapang@cuhk.edu.hk

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Locations (1)

Chinese University of Hong KongShatin, Hong Kong, Hong KongRecruiting

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Source record: clinicaltrials.gov/study/NCT06439810