Measuring TB DNA in blood and urine
Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level in Diagnosing TB and Treatment Monitoring
Chinese University of Hong Kong · NCT07170735
This test checks whether measuring Mycobacterium tuberculosis cell-free DNA in blood and urine can detect active TB in hospitalized patients and distinguish them from people with latent TB or no infection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 2 sites (Hong Kong, Hong Kong and 1 other locations) |
| Trial ID | NCT07170735 on ClinicalTrials.gov |
What this trial studies
This observational study collects plasma and urine from three groups: adults newly hospitalized with diagnosed TB, adults with latent TB infection (LTBI) confirmed by TST or IGRA, and controls without TB or LTBI. Samples will undergo molecular assays to quantify MTB cell-free DNA (cfDNA) using PCR-based methods. Results will be compared to routine microbiological, histological, and clinical diagnoses to determine how well plasma and urine cfDNA levels correlate with disease status. The study excludes patients who have received effective anti-TB treatment for more than 24 hours, individuals under 18, and those with life expectancy under 12 months.
Who should consider this trial
Good fit: Ideal candidates are adults newly hospitalized with diagnosed TB, adults with LTBI confirmed by TST or IGRA, or adults without TB or LTBI willing to provide blood and urine samples at the Prince of Wales Hospital.
Not a fit: People already on effective anti-TB therapy for more than 24 hours, children under 18, and those with expected survival under 12 months are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, a blood or urine MTB cfDNA test could offer a less invasive and faster way to detect TB, especially for people who cannot produce sputum or who have extrapulmonary disease.
How similar studies have performed: Prior small studies have detected MTB cfDNA in plasma and urine with promising results, but larger validation studies remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * TB group: patients hospitalized for newly diagnosed TB disease. * LTBI group: patients without TB disease, but with LTBI diagnosed by either tuberculin skin test (TST) or an interferon-gamma release assay (IGRA) blood test. * Control group: patients or healthy volunteers without TB disease and LTBI Exclusion Criteria: * Initiation of an effective anti-TB treatment regimen more than 24 hours * Aged 17 years or younger * Life expectancy of less than 12 months
Where this trial is running
Hong Kong, Hong Kong and 1 other locations
- Prince of Wales Hospital — Hong Kong, Hong Kong, Hong Kong (NOT_YET_RECRUITING)
- Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Ka Pang Chan, MBChB
- Email: chankapang@cuhk.edu.hk
- Phone: 35052211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis