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Simple fluid test could replace needle biopsy for TB of the lung lining

NCT ID NCT06646237

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests a new liquid biopsy that measures TB DNA in fluid from around the lungs to diagnose tuberculous pleuritis, a common form of TB. Current methods often require invasive tissue biopsies or have low accuracy. The trial will enroll 350 adults with new-onset pleural effusion to see if this simple fluid test can reliably tell TB from other causes, potentially avoiding the need for a biopsy.

What this could mean

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

Active substance
MTB cell-free DNA assay (liquid biopsy)
What this could lead to
If successful, this could provide a quick, less invasive way to diagnose tuberculous pleuritis, reducing the need for tissue biopsies.
What could go wrong
The test was developed on a small, selected group, so it may not work as well in a broader, real-world population. Also, it is still being validated and is not yet available for routine use.

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 350 people

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

Started

Jan 2026

Expected to finish

Dec 2028

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 definite or probably TBP will be recruited as positive control. Patients without TBP will be recruited as negative control.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Patients hospitalised for new-onset unilateral pleural effusion. * Thoracentesis will be performed for pleural fluid analysis. * Age equals or is above 18 years old * Written informed consent is obtained Exclusion Criteria: * History of intrapleural therapy (including talc and fibrinolytic), surgical decortication or surgical pleurodesis in the ipsilateral pleural space in the past 3 months * Concomitant use of at least two anti-TB medications (including isoniazid, rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin, moxifloxacin, linezolid) for more than consecutive 7 days in the past 3 months * Failed to obtain informed consent due to patient's refusal or cognitive impairment. * History of TBP in the ipsilateral pleural space * Expected survival of less than three months from a different pathology (e.g. advanced metastatic malignancy) as that further pleural investigations may not be able to carry out if negative initial workup. * Use of agents under research or not registered in the 30 days prior to the study

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Conditions

The condition(s) this trial relates to.

pleural tuberculosis tuberculosis

As listed by the trial registrant

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

Pleural biopsy Tuberculosis, pleural

How to take part

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

  1. The places running it

    1 site. 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

  • Chinese University of Hong Kong

    RECRUITING

    Hong Kong, Hong Kong, Hong Kong

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