NCT07230457

Plasma MTB cfDNA Before Bronchoscopy

Not yet recruiting Last updated 17 November 2025

What this trial tests

trial testing Diagnostic Test: Plasma MTB cfDNA assay in Tuberculosis Diagnosis in 600 participants. Not yet recruiting.

Timeline

1 October 2026

Primary endpoint
31 December 2028

30 June 2029

Quick facts

Lead sponsor	Chinese University of Hong Kong
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	600
Start date	1 October 2026
Primary completion	31 December 2028
Estimated completion	30 June 2029
Sites	1 location across Hong Kong

Drugs / interventions tested

• Diagnostic Test: Plasma MTB cfDNA assay

Conditions studied

• Tuberculosis Diagnosis — all drugs for Tuberculosis Diagnosis →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Tuberculosis Diagnosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tuberculosis (TB) remains a major global health challenge, affecting over 10 million people annually. Hong Kong carries an intermediate TB burden, with \~3,200 new cases reported yearly. Pulmonary TB (PTB), the most common form, presents diagnostic difficulties. Traditional methods like sputum smear and culture often fail in patients unable to produce adequate samples, necessitating bronchoscopy to collect bronchoalveolar lavage (BAL) for mycobacterial testing.

These limitations pose risks for patients and strain healthcare systems. Bronchoscopy is invasive, resource-intensive, and may delay treatment-especially for elderly patients with comorbidities. Blood-based inflammatory markers lack diagnostic specificity. A rapid, non-invasive alternative is urgently needed.

The investigators developed a plasma-based assay that detects Mycobacterium tuberculosis cell-free DNA (MTB cfDNA) in blood. This liquid biopsy leverages metagenomic sequencing and computational analysis to identify TB-specific genetic material while minimizing contamination. Preliminary data show excellent diagnostic performance, with area under the receiver operating characteristic curve values \>0.94 for TB pleurisy.

The investigators propose a prospective clinical validation study comparing plasma MTB cfDNA testing to bronchoscopy with BAL culture and molecular testing. The primary aim is to demonstrate non-inferiority of plasma cfDNA within a 10% sensitivity margin. Secondary aims include assessing how clinical and radiological features affect test performance and evaluating the assay's ability to detect drug resistance mutations for personalized therapy.

Validation could transform TB diagnosis by offering a rapid, safe, and accurate blood test. Patients could avoid invasive procedures, receive faster diagnoses, and begin treatment sooner. Detecting resistance mutations directly from plasma would enable timely, targeted therapy-critical for addressing multidrug-resistant TB. This represents a paradigm shift toward precision medicine in TB care.

Tailored to Hong Kong's epidemiological context, this study addresses a key diagnostic gap. The approach has global relevance, with potential to improve clinical outcomes, reduce costs, and accelerate progress toward WHO's TB elimination goals.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.