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Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA

Recruitingn/aAges 18 Years - anyAllChinese University of Hong Kong
NCT06439810 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 press

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📋 Eligibility rules (as published)
Inclusion Criteria: * New-onset pleural effusion planning for thoracentesis * Age 18 years or above * Able to give informed consent Exclusion Criteria: * History of TBP or intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space. Patients with a history of TB outside the pleural space completed anti-TB treatment can be included * History of surgical intervention (including decortication, pleurodesis, lung resection) in the ipsilateral pleural space * Concomitant use of at least two anti-TB medications (including isoniazid, rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin, moxifloxacin, linezolid) for more than consecutive 7 days in the past 3 months * Consent not obtained from the participants
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What it tests

  • Mycobacterium tuberculosis (MTB) cell-free DNA (cfDNA)
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Where

1 site
Chinese University of Hong Kong
Shatin, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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