RecruitingNot ApplicableNCT07168993

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.

Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline


Sponsor

bioAffinity Technologies Inc.

Enrollment

2,063 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new non-invasive sputum (mucus) test to detect lung cancer in people who are at high risk because they have a lung nodule found on a CT scan. You may be eligible if... - You are between 50 and 80 years old - You are a current or former smoker with at least 20 pack-years of smoking history (you quit within the past 15 years if a former smoker) - You have a lung nodule between 6 and 30 mm found on a CT scan - You are able to cough up a sputum (mucus) sample You may NOT be eligible if... - You cannot produce a sputum sample due to severe lung disease - Your nodule is a specific type (ground glass or mostly ground glass) or in certain locations - You are immune-suppressed, have rheumatoid arthritis, or have been diagnosed with lung cancer in the past 5 years or another cancer in the past 2 years - You have angina with minimal physical effort - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard medical treatment

Standard of care follow up per institution

OTHERStandard medical treatment

SOC per institution


Locations(3)

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania, United States

Audie Murphy VA Medical Center

San Antonio, Texas, United States

Brooke Army Medical Center

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07168993


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