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Simple spit test could spot lung cancer early

NCT ID NCT07168993

Diagnosis Sponsor: bioAffinity Technologies Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 2 times

Summary

This study is testing a new test called FlowPath Lung that looks for signs of lung cancer in sputum (phlegm). It involves over 2,000 high-risk individuals aged 50-80 who have lung nodules found on CT scans. The goal is to see if this non-invasive test can accurately detect early-stage lung cancer, potentially offering a simpler alternative to more invasive procedures.

What this could mean

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

What this could lead to
If successful, this could provide a simple, non-invasive sputum test to catch lung cancer early, potentially reducing the need for biopsies and improving survival rates.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. The test may not be accurate enough to replace current methods, and results may not apply to all populations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,063 people

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

Started

Feb 2026

Expected to finish

Jul 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.

Ages

50 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. Is able to give signed informed consent and comply with study requirements. 2. Is high risk for getting lung cancer: 1. ≥50 - 80 years of age. 2. current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years. 3. Has a \>6 to \<30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 6 weeks of the prestudy baseline CT scan. 3a) Nodule is either new, increasing, or stable for ≤ 6 months. 3b) In cases where a person has multiple nodules as determined by CT scan, the subject's most suspicious nodule is \>6 to \<30 mm in diameter. 4\) Is willing to provide contact information to the study PI or the treating physician(s) who can release required medical information related to SOC follow-up. Exclusion Criteria: 1. Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease). 2. The dominant nodule is ground glass or part solid as determined by CT scan. 3. Has 5 or more nodules sized \>4 mm. 4. The nodule sized \>6 to \<30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule. 5. Is immunosuppressed. 6. Has rheumatoid arthritis. 7. Had lung cancer diagnosis in the past 5 years or any other cancer (other than non-melanoma skin cancer) in the past 2 years. A subject on long-term medications used for prevention of cancer, such as Tamoxifen for breast cancer, is not excluded. 8. Has angina with minimal exertion. 9. Is currently pregnant or planning on becoming pregnant during this study.

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Conditions

The condition(s) this trial relates to.

disease lung cancer lung neoplasm

As listed by the trial registrant

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

Lung cancer (diagnosis)

How to take part

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

  1. The places running it

    11 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

  • Audie Murphy VA Medical Center

    RECRUITING

    San Antonio, Texas, 78234, United States

  • Bay Pines VA Healthcare System

    RECRUITING

    Bay Pines, Florida, 33744, United States

  • Brooke Army Medical Center

    RECRUITING

    San Antonio, Texas, 78234, United States

  • Captain James A. Lovell Federal Health Care Center

    RECRUITING

    North Chicago, Illinois, 60064, United States

  • Clinical Research Associates of Central Pennsylvania

    RECRUITING

    DuBois, Pennsylvania, 15801, United States

  • Dayton VA Medical Center

    RECRUITING

    Dayton, Ohio, 45428, United States

  • James A. Haley Veterans' Hospital

    RECRUITING

    Tampa, Florida, 33612, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Miami VA Healthcare System

    RECRUITING

    Miami, Florida, 33125, United States

  • VA Palo Alto Health Care System

    RECRUITING

    Palo Alto, California, 94304, United States

  • VA Western Colorado Health Care System

    RECRUITING

    Grand Junction, Colorado, 81501, United States

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