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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 12 weeks (3 months) 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 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 it's running

• VA Palo Alto Health Care System
  Palo Alto, California, United States Recruiting
• VA Western Colorado Health Care System
  Grand Junction, Colorado, United States Recruiting
• Bay Pines VA Healthcare System
  Bay Pines, Florida, United States Recruiting
• Miami VA Healthcare System
  Miami, Florida, United States Recruiting
• James A. Haley Veterans' Hospital
  Tampa, Florida, United States Recruiting
• Captain James A. Lovell Federal Health Care Center
  North Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Xavier T Reveles, MS, CG(ASCP)
• Email: xr@bioaffinitytech.com
• Phone: 210-698-5334

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.