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.
Condition(s) studied
Investigational drug(s) / intervention(s)
Standard medical treatment: Standard of care follow up per institution
Standard medical treatment: SOC per institution
Study 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
Primary outcome measure(s)
- Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum — From Baseline Sputum Sample provided by subject through 24 months follow up period.
Evaluate the clinical performance (positive percent agreement \[PPA/sensitivity\] and negative percent agreement \[NPA/specificity\]) of the FlowPath Lung test in predicting lung cancer from the sputum of high-risk individuals with lung nodules
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | Recruiting |
| VA Western Colorado Health Care System | Grand Junction | Colorado | Recruiting |
| Bay Pines VA Healthcare System | Bay Pines | Florida | Recruiting |
| Miami VA Healthcare System | Miami | Florida | Recruiting |
| James A. Haley Veterans' Hospital | Tampa | Florida | Recruiting |
| Captain James A. Lovell Federal Health Care Center | North Chicago | Illinois | Recruiting |
| Dayton VA Medical Center | Dayton | Ohio | Recruiting |
| Clinical Research Associates of Central Pennsylvania | DuBois | Pennsylvania | Recruiting |
| Audie Murphy VA Medical Center | San Antonio | Texas | Recruiting |
| Brooke Army Medical Center | San Antonio | Texas | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
More bioAffinity Technologies Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07168993 on ClinicalTrials.gov ↗ ← All trials in the USA