Blood TB DNA test to track treatment progress
Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study
This project will test whether levels of TB-derived cell-free DNA in the blood can track treatment response in adults newly diagnosed with tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Tak) |
| Trial ID | NCT06845618 on ClinicalTrials.gov |
What this trial studies
This observational feasibility project at the Mae RaMat TB Center (Shoklo Malaria Research Unit, Tak, Thailand) will measure Mycobacterium tuberculosis-derived cell-free DNA (Mtb-cfDNA) in blood samples. The work includes an assay development and validation arm plus a longitudinal cohort of adults with newly microbiologically confirmed TB sampled before and during standard therapy, with healthy adult controls. Mtb-cfDNA levels will be compared over time with conventional culture or nucleic acid test results to see if changes correlate with treatment response. The study is funded by the Wellcome Trust and aims to determine whether a blood-based cfDNA biomarker could be a practical tool for monitoring TB treatment.
Who should consider this trial
Good fit: Ideal participants are adults (≥18) with a new microbiologically confirmed diagnosis of TB who have not yet started antituberculosis therapy, with healthy adult volunteers enrolled as controls.
Not a fit: People who have recently received antituberculosis treatment, are pregnant, have active malignancy, are transfusion-dependent, or who have past or latent TB (for healthy volunteer group) are excluded and are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, a simple blood test could give earlier, noninvasive signals of whether TB treatment is working, helping clinicians make faster treatment decisions and supporting drug development.
How similar studies have performed: Early pilot work and related cfDNA research in infectious diseases and oncology have shown promise detecting pathogen DNA, but use of Mtb-cfDNA specifically for monitoring treatment is still early-stage and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants with a new diagnosis of tuberculosis * Aged ≥ 18 years old * Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site) * Has not yet commenced antituberculosis therapy * Able to understand study procedures and requirements and is able to give informed consent For healthy volunteers: * Aged ≥ 18 years old * Healthy as judged by a responsible physician * Able to understand study procedures and requirements and is able to give informed consent Exclusion Criteria: Participants with a new diagnosis of tuberculosis * Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone) * Known history of underlying malignancy * Pregnancy * Transfusion dependent anaemia For healthy volunteers: * History of tuberculosis infection or latent tuberculosis infection * Household, or other close contact, of a person living with tuberculosis disease * Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis * Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \> 2 weeks duration, fever, weight loss, night sweats) * Other major medical comorbidity * Pregnancy * Known malignancy
Where this trial is running
Tak
- Shoklo Malaria Research Unit (SMRU) — Tak, Thailand (Recruiting)
Study contacts
- Principal investigator: Timothy Seers, Dr — Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.
- Study coordinator: Htet Ko Ko Aung, Dr
- Email: htetkoko@shoklo-unit.com
- Phone: 055 581 135
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.