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Simple blood test could spot lung cancer early in heavy smokers

NCT ID NCT06816121

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 2 times

Summary

This study is testing a new blood test to find early-stage lung cancer in heavy smokers who have no symptoms. Researchers will collect blood samples from 350 current or former smokers aged 30-80, including those with and without lung cancer. The goal is to see if the test can detect cancer early, when it's easier to treat. Participants give blood at the start and after 12 and 24 months, but results are not shared with them or their doctors.

What this could mean

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

Active substance
blood-based biomarker test
What this could lead to
If successful, this could lead to a simple blood test that catches lung cancer early in heavy smokers, when it's more treatable.
What could go wrong
This is an early observational study, not a treatment trial. The test may not be accurate enough, and results are not shared with participants or doctors.

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

Feb 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

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

Both smokers that meet USPSTF criteria for annual LD-CT screening (age 50-80, smoked \>20 pack years, quit \<15yr ago if former smoker) to younger (\>30 years) and lighter smokers (\>10 pack years)

Ages

30 to 80 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: All Participants: * Understands the study and can provide written informed consent * Willing and able to provide a blood sample * Age 30-80 * Current or former smoker Non-Cancer Cohort: * Recent CT scan within 3 months AND * No lung nodules (Lung-RADS 1) or benign/stable nodules Indeterminate Cohort: * Recent CT scan within 12 months AND * Indeterminate lung nodules under active monitoring Highly Suspicious or Confirmed Lung Cancer Cohort: * Confirmed untreated lung cancer OR * Highly suspicious lung nodules undergoing diagnostic work-up Other Cancer Cohort: \- Confirmed, untreated cancer associated with smoking Exclusion Criteria: * Cancer diagnosis within the last 5 years * Systemic therapy, radiation, or surgery for cancer within 1 year prior to enrollment * Any history of hematologic malignancies or myelodysplasia * Known infection with HIV, HCV, or HBV * Active pregnancy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Site 101

    RECRUITING

    Oklahoma City, Oklahoma, 73102, United States

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