Mycobacterium tuberculosis cell-free DNA for diagnosing pleural tuberculosis
Official title: Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA (MTB cfDNA) in Tuberculous and Non-tuberculous Pleural Effusion
Run by Chinese University of Hong Kong · NCT06439810 · Data updated 2026-11-12
This test tries measuring MTB cell-free DNA in pleural fluid to see if it can diagnose pleural tuberculosis in adults with new pleural effusions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, Hong Kong) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT06439810 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a new pleural effusion scheduled for thoracentesis who can give informed consent and have no prior ipsilateral pleural TB or recent ipsilateral pleural surgery or intrapleural therapy.
✕Probably not a fit
Patients with prior ipsilateral pleural surgery or interventions, those already on multiple anti-TB drugs recently, children, or people unable to attend the Hong Kong site or give consent are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects pleural fluid at planned thoracentesis from adults with new-onset pleural effusion and measures Mycobacterium tuberculosis cell-free DNA (cfDNA). Results will be compared with standard diagnostic methods such as culture, molecular PCR tests, pleural biopsy/histology when available, and routine biomarkers like adenosine deaminase. The goal is to determine the diagnostic performance (sensitivity and specificity) of cfDNA for tuberculous pleuritis. The study enrolls consenting adults without prior ipsilateral pleural interventions or recent multi-drug anti-TB treatment.
Why it matters
Potential benefit: If successful, this could enable earlier, less invasive, and more accurate diagnosis of tuberculous pleuritis from pleural fluid.
How similar studies have gone: Molecular tests like Xpert/Xpert Ultra and ADA have shown utility but limited sensitivity for pleural TB, and use of MTB cfDNA is relatively novel with limited published diagnostic evidence so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Chinese University of Hong Kong
Shatin, Hong Kong, Hong Kong Recruiting
Study contacts
- Principal investigator: Ka Pang Chan, MBChB — Prince of Wales Hospital, Shatin, Hong Kong
- Study coordinator: Ka Pang Chan, MBChB
- Email: chankapang@cuhk.edu.hk
- Phone: 35052211
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.