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DNA test could spot lung cancer in tiny biopsy samples

NCT ID NCT05415670

Diagnosis Sponsor: Geneplus-Beijing Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new DNA methylation test (GM-seq) on small lung nodule samples taken during bronchoscopy. The goal was to see if the test could accurately tell benign nodules from malignant ones, using final surgical pathology as the gold standard. Researchers enrolled 158 people with lung nodules 1-3 cm in size. If the test works well, it could improve early lung cancer diagnosis and reduce the need for more invasive procedures.

What this could mean

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

Active substance
Whole-genome methylation sequencing (GM-seq) test
What this could lead to
If successful, this test could help doctors diagnose lung cancer earlier and more accurately from small biopsy samples, reducing unnecessary surgeries.
What could go wrong
This is a small, completed study with 158 participants. The test may not be accurate enough for widespread use, and results need confirmation in larger, diverse groups.

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

158 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Subjects with pulmonary nodules suspected of early lung cancer

Ages

20 to 75 years

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: 1. Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT; 2. The nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection; 3. Patient accept imaging evaluation without advanced lung tumors and metastases; 4. The location of the nodule in the lung is within the reach of lung biopsy under bronchoscope; 5. provide the collected clinical data needed by the research; 6. Patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits. Exclusion criteria: 1. Unwilling to accept the invasive examination and treatment of this study; 2. Contraindication of tracheoscopy; 3. Consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer; 4. Those who cannot tolerate resection of pulmonary nodules; 5. Accompanied by other malignant tumors; 6. In the judgment of the researcher, the patient also suffers from other serious diseases that may affect the accuracy of the test; 7. Those who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT); 8. Any other illness, social / psychological problems, etc. are judged by the researcher to be unsuitable for participating in this study.

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Conditions

The condition(s) this trial relates to.

pulmonary coin lesion

As listed by the trial registrant

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

Pulmonary nodule, solitary Whole-genome methylation sequencing

Contacts and locations

Locations

  • Beijing hospital

    Beijing, Beijing Municipality, 100730, China

  • Emergency general hospital

    Beijing, Beijing Municipality, 100028, China

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