FlowPath Lung Test for Lung Cancer Detection

This study is evaluating a new test called the FlowPath Lung Test. This test uses sputum samples (mucus coughed up from the lungs) to see if it can accurately find lung cancer in people who are at high risk. You might be able to join if you are between 50 and 80 years old, have a history of smoking, and have lung nodules (small growths) between 6 and 30 millimeters that were found by a low-dose CT scan (LDCT). The main goal is to see how well the FlowPath Lung Test can detect early-stage lung cancer. The study plans to enroll 2063 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 2063 participants. It is evaluating a diagnostic test for lung cancer.
What's involved
You would provide a baseline sputum sample and be followed for up to 24 months. You would also receive standard medical care as determined by your institution.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months after providing a baseline sputum sample.

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NCT07168993

Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.

Recruiting
NAAges 50–80InterventionalDiagnostic
bioAffinity Technologies Inc.
~2,063 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Standard medical treatment

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum
Measured over From Baseline Sputum Sample provided by subject through 24 months follow up period.
Lung Cancer (Diagnosis)
11 sites across 8 states
Florida3
Texas2
California1
Colorado1
Illinois1
Ohio1
Pennsylvania1
Wisconsin1
  • Maria Zannes · STUDY_CHAIR · bioAffinity Technologies Inc.

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  • Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in SputumFrom Baseline Sputum Sample provided by subject through 24 months follow up period.

    Evaluate the clinical performance (positive percent agreement \[PPA/sensitivity\] and negative percent agreement \[NPA/specificity\]) of the FlowPath Lung test in predicting lung cancer from the sputum of high-risk individuals with lung nodules