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 now · Not applicable
Conditions studied: Lung Cancer (Diagnosis)
In brief
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.
Key facts
- Study ID
- NCT07168993
- Run by
- bioAffinity Technologies Inc.
- People needed
- 2063
- Starts
- 2026-02-25
- Expected to finish
- 2029-07-01
- Last updated by the study team
- 2026-07-16
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is able to give signed informed consent and comply with study requirements.
- Is high risk for getting lung cancer:
- ≥50 - 80 years of age.
- 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.
- 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.
- 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.
You may not qualify if…
- Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
- The dominant nodule is ground glass or part solid as determined by CT scan.
- Has 5 or more nodules sized >4 mm.
- The nodule sized >6 to <30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.
- Is immunosuppressed.
- Has rheumatoid arthritis.
- 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.
- Has angina with minimal exertion.
- Is currently pregnant or planning on becoming pregnant during this study.
Where it is running
- VA Palo Alto Health Care System — Palo Alto, California, United States (enrolling)
- VA Western Colorado Health Care System — Grand Junction, Colorado, United States (enrolling)
- Bay Pines VA Healthcare System — Bay Pines, Florida, United States (enrolling)
- Miami VA Healthcare System — Miami, Florida, United States (enrolling)
- James A. Haley Veterans' Hospital — Tampa, Florida, United States (enrolling)
- Captain James A. Lovell Federal Health Care Center — North Chicago, Illinois, United States (enrolling)
- Dayton VA Medical Center — Dayton, Ohio, United States (enrolling)
- Clinical Research Associates of Central Pennsylvania — DuBois, Pennsylvania, United States (enrolling)
- Audie Murphy VA Medical Center — San Antonio, Texas, United States (enrolling)
- Brooke Army Medical Center — San Antonio, Texas, United States (enrolling)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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