FlowPath Lung sputum test to detect cancer in people with 6–30 mm lung nodules

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

This test will try to detect lung cancer from a sputum sample using the FlowPath Lung assay in high‑risk people aged 50–80 who have a 6–30 mm lung nodule found on CT.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2063 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: bioAffinity Technologies Inc. (industry)
• Locations: 3 sites (DuBois, Pennsylvania and 2 other locations)
• Trial ID: NCT07168993 on ClinicalTrials.gov

What this trial studies

Researchers will collect sputum samples from high‑risk adults (age 50–80 with a ≥20 pack‑year smoking history) who have a 6–30 mm lung nodule identified by low‑dose CT. Samples will be analyzed with the Flow Cytometry – FlowPath Lung test to identify cell patterns or markers associated with lung cancer. Test results will be compared to standard-of-care diagnostic follow-up, including imaging and any biopsy or pathology, to measure sensitivity and specificity. Participants must provide sputum within six weeks of the baseline CT and agree to release medical records for follow-up.

Who should consider this trial

Good fit: Ideal candidates are people 50–80 years old with a ≥20 pack‑year smoking history (current smokers or those who quit within 15 years) who have a most‑suspicious lung nodule measuring 6–30 mm and can provide a sputum sample.

Not a fit: People with nodules smaller than 6 mm or 30 mm or larger, those unable to produce sputum, or those with a confirmed lung cancer diagnosis are unlikely to benefit from this test.

Why it matters

Potential benefit: If successful, the test could provide a simple, non‑invasive way to help detect lung cancer earlier and may reduce unnecessary invasive biopsies.

How similar studies have performed: Previous sputum- and blood-based biomarker tests have shown promising but inconsistent accuracy, so non‑invasive approaches like FlowPath are emerging but not yet standard of care.

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.

Where this trial is running

DuBois, Pennsylvania and 2 other locations

• Clinical Research Associates of Central Pennsylvania — DuBois, Pennsylvania, United States (RECRUITING)
• Audie Murphy VA Medical Center — San Antonio, Texas, United States (RECRUITING)
• Brooke Army Medical Center — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Xavier T Reveles, MS, CG(ASCP)

Conditions: Lung Cancer, Diagnostic Test, Sputum Assay