An observational study in Mycobacterium Tuberculosis, Tuberculosis, Pulmonary and Tuberculosis, Extra-Pulmonary, sponsored by University of Oxford. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Oxford · Observational
Tuberculosis (TB) is a leading infectious cause of death worldwide. Current strategies for monitoring TB treatment response are culture dependent and insensitive. New methods of assessing treatment response in vivo could inform new drug development and other treatment strategies. Cell-free DNA (cfDNA) - small circulating fragments of DNA - is widely used in maternofetal medicine and oncology for diagnosis and assessment of treatment response. This study aims to investigate whether pathogen derived Mycobacterium tuberculosis-specific cfDNA (Mtb-cfDNA) can be used to monitor TB treatment response.
This feasibility study will take place at Mae RaMat TB Center in Thailand and includes two study groups:
This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 140 is below the median of 300 across 83 observational studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group 1: Assay development and validation. In this group, sampling will be performed at tuberculosis diagnosis. Tuberculosis participants (n = 20) will have blood sampling performed at day 0. Healthy participants (n = 20) without clinical evidence of tuberculosis will have blood sampling performed at a single timepoint.
Group 2: Longitudinal Assessment. In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will help to establish the feasibility of dynamic Mtb-cfDNA measurements.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with a new diagnosis of tuberculosis
For healthy volunteers:
Exclusion Criteria:
Participants with a new diagnosis of tuberculosis
For healthy volunteers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twenty participants with a new diagnosis of tuberculosis will have venous blood collected prior to treatment initiation. Twenty participants without clinical evidence of tuberculosis infection will be recruited from the local community as a control during assay validation. This group of the study participants will be assessed at day zero only.
In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will establish the feasibility of dynamic Mtb-cfDNA measurements for the assessment of tuberculosis treatment response.
Mtb-cfDNA trajectories
Rate of Mtb-cfDNA clearance derived from serial Mtb-cfDNA measurements
Time frame: Day 0 - 168 (or end of treatment)
Percentage of participants completing sampling schedule
Time frame: Day 0 - 168 (or end of treatment)
Exploratory analysis is planned and will compare Mtb-cfDNA levels to clinical, microbiological and radiological features
Time frame: Day 0 - 168 (or end of treatment)
Plan to share: Yes — The data generated in this study belongs to the study group as a whole. The final database will be shared amongst the PI and key members of the research team. With participant's consent, clinical data and results from blood analyses stored in the database may be shared with researchers not directly involved in this study but only after the main paper has been published and in accordance with MORU guidelines on data sharing. The results of the study will be summarised in lay language, in both English and the language(s) commonly spoken at the study site, and disseminated to participants and the community. The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authorship will be determined in accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines and other contributors will be acknowledged.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Sep 2027, 26 months after the start.
Of 44 observational studies under Tuberculosis, Pulmonary, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's planned 26 months is below that.
How these figures are worked out, and which studies are left out of them.
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