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New blood test could speed up TB diagnosis

NCT ID NCT07170735

Diagnosis Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether measuring TB DNA in blood and urine can help diagnose tuberculosis and track treatment progress. Current TB tests can be slow or require invasive procedures. The trial will enroll 85 people with active TB, latent TB, or no TB to see how accurate the new test is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Plasma and urine MTB cfDNA assay
What this could lead to
If successful, this could lead to a simple blood or urine test for faster, non-invasive TB diagnosis and treatment monitoring.
What could go wrong
This is an early exploratory study with only 85 participants. The test may not be accurate enough or may not work for all types of TB.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with active TB disease will be recruited as positive control. Patients with latent TB infection, and subjects without active TB disease and latent TB infection will be recruited as negative control.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

latent tuberculosis infection tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Prince of Wales Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong, Hong Kong

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong

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