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Blood test may spot lung cancer sooner in High-Risk patients

NCT ID NCT07615556

Diagnosis Sponsor: The 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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study is testing whether a blood test that looks for genetic changes (ctDNA) can help detect lung cancer early in people who have suspicious lung nodules found on CT scans. Researchers will collect blood samples from 200 participants in Hong Kong and Vietnam at the start and after 6 months, and compare the results with follow-up CT scans. The goal is to see if the blood test can improve the accuracy of lung cancer diagnosis and reduce unnecessary procedures.

What this could mean

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

Active substance
ctDNA mutations and methylation with SPOTMAS Lung assays (blood test)
What this could lead to
If successful, this blood test could help doctors identify lung cancer earlier in people with suspicious lung nodules, potentially reducing unnecessary biopsies and improving outcomes.
What could go wrong
This is an early-stage study with only 200 participants, so results may not apply to everyone. The test might not be accurate enough to replace current methods, and false positives or negatives are possible.

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 200 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

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

People with suspicious lung nodules on CT Thorax

Ages

45 to 80 years

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: 1. Age 45 - 80 years; 2. Suspicious lung nodules (\> 0.5 - 30mm in longest diameter, non-calcified) found within the past six months, or if PET scan has been done before, the specific uptake value (SUV) should be more than 1 Exclusion Criteria: 1. Age \< 45 or \> 80; 2. Lung nodules of \< 0.5 cm in longest diameter, or with calcification seen in imaging; 3. Known lung cancer or lung metastasis before, or history of extra-pulmonary cancer; 4. Active tuberculosis; 5. Clinical unstable conditions including untreated ischemic heart disease or arrhythmia, uncontrolled airway disease; 6. Unwillingness to undergo invasive investigation like bronchoscopy; 7. Unable to provide informed written consent.

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Conditions

The condition(s) this trial relates to.

lung cancer

As listed by the trial registrant

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

Early detection of lung cancer Lung cancer screening Lung nodules Suspected lung cancer Suspicious lung nodules (> 0.5 - 30MM in longest diameter, non-calcified) Suspicious lung nodules, with suv more than 1

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

  • University of Hong Kong Queen Mary Hospital

    Hong Kong, Hong Kong

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