Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level

Plain-language summary

This study examines the quantitative measurement of Mycobacterium tuberculosis (MTB) cell-free DNA levels in blood (plasma) and urine in tuberculosis disease. Patients newly diagnosed with tuberculosis, people with latent tuberculosis infection, and control participants without the disease may take part. This is a study without a clinical phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Chinese University of Hong Kong

Intervention

Plasma MTB cfDNA assay, Urine MTB cfDNA assay

Start date

2/1/2026

Estimated completion

7/31/2027

Countries

Hong Kong

Related genes

Locations

• Hong Kong, Hong Kong
• Hong Kong, Hong Kong

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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