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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

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

Who can join

Ages 50 to 80 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: bioAffinity Technologies Inc. · Participants: 2,063 · Started: Feb 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07168993

Locations in the U.S.

CaliforniaVA Palo Alto Health Care System, Palo Alto
ColoradoVA Western Colorado Health Care System, Grand Junction
FloridaBay Pines VA Healthcare System, Bay Pines
Miami VA Healthcare System, Miami
James A. Haley Veterans' Hospital, Tampa
IllinoisCaptain James A. Lovell Federal Health Care Center, North Chicago
OhioDayton VA Medical Center, Dayton
PennsylvaniaClinical Research Associates of Central Pennsylvania, DuBois
TexasAudie Murphy VA Medical Center, San Antonio
Brooke Army Medical Center, San Antonio
WisconsinMedical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.