Diagnosis aid for pleural TB using blood and pleural fluid DNA in Hong Kong
Official title: Liquid Biopsy by Measuring Pleural Fluid Mycobacterium Tuberculosis Cell-free DNA (MTB cfDNA) Level to Diagnose Tuberculous Pleuritis in a Real-world Setting
Run by Chinese University of Hong Kong · NCT06646237 · Data updated 2026-11-12
This study checks whether cell-free DNA from Mycobacterium tuberculosis in pleural fluid can help diagnose tuberculous pleural effusion in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Hong Kong) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT06646237 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older hospitalized with new unilateral pleural effusion undergoing thoracentesis.
✕Probably not a fit
Patients with non-tuberculous causes of effusion or those whose pleural TB cannot be detected by MTB cell-free DNA may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Tuberculous pleuritis is a common form of extrapulmonary TB with non-specific symptoms and challenging diagnosis. This observational study examines the potential use of Mycobacterium tuberculosis cell-free DNA in pleural fluid to improve diagnostic accuracy beyond conventional tests. Participants are adults with new unilateral pleural effusion undergoing thoracentesis. The study analyzes pleural fluid samples to detect MTB cell-free DNA and compare performance with standard microbiological and biomarker assays. No interventional procedures are described beyond routine diagnostic sampling, and results may inform future diagnostic approaches for TBP in Hong Kong.
Why it matters
Potential benefit: If successful, this approach could shorten diagnostic time and reduce the need for invasive procedures by improving accuracy in identifying tuberculous pleural effusion.
How similar studies have gone: Prior studies have shown promise for DNA-based biomarkers in TB diagnostics, but results for MTB cell-free DNA in pleural fluid are emerging and not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients hospitalised for new-onset unilateral pleural effusion. * Thoracentesis will be performed for pleural fluid analysis. * Age equals or is above 18 years old * Written informed consent is obtained Exclusion Criteria: * History of intrapleural therapy (including talc and fibrinolytic), surgical decortication or surgical pleurodesis in the ipsilateral pleural space in the past 3 months * 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 * Failed to obtain informed consent due to patient's refusal or cognitive impairment. * History of TBP in the ipsilateral pleural space * Expected survival of less than three months from a different pathology (e.g. advanced metastatic malignancy) as that further pleural investigations may not be able to carry out if negative initial workup. * Use of agents under research or not registered in the 30 days prior to the study
Where it's running
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Chinese University of Hong Kong
Hong Kong, Hong Kong, Hong Kong Recruiting
Study contacts
- Study coordinator: Ka Pang Chan, MBChB
- Email: chankapang@cuhk.edu.hk
- Phone: 35052211
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Mycobacterium tuberculosis cell-free DNA for diagnosing pleural tuberculosis
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.
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.