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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.
Sponsor: bioAffinity Technologies Inc.
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.
Official title: Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline
Key Details
Gender
All
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
2063
Start Date
2026-02-25
Completion Date
2029-07-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Standard medical treatment
Standard of care follow up per institution
Standard medical treatment
SOC per institution
Locations (3)
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States
Audie Murphy VA Medical Center
San Antonio, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States