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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,063
Standard of care follow up per institution
SOC per institution
VA Palo Alto Health Care System
Palo Alto, California, United States
RECRUITINGVA Western Colorado Health Care System
Grand Junction, Colorado, United States
RECRUITINGBay Pines VA Healthcare System
Bay Pines, Florida, United States
RECRUITINGMiami VA Healthcare System
Miami, Florida, United States
RECRUITINGJames A. Haley Veterans' Hospital
Tampa, Florida, United States
RECRUITINGCaptain James A. Lovell Federal Health Care Center
North Chicago, Illinois, United States
RECRUITINGDayton VA Medical Center
Dayton, Ohio, United States
RECRUITINGClinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States
RECRUITINGAudie Murphy VA Medical Center
San Antonio, Texas, United States
RECRUITINGBrooke Army Medical Center
San Antonio, Texas, United States
RECRUITING...and 1 more locations
Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum
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
Time frame: From Baseline Sputum Sample provided by subject through 24 months follow up period.
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