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.

Part of paid clinical trials in Palo Alto, California.

Sponsor
bioAffinity Technologies Inc.
Study ID
NCT07168993
Status
Recruiting
Apply to this trial

Conditions

  • Lung Cancer (Diagnosis)

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard medical treatment — OTHER
    Standard of care follow up per institution
  • Standard medical treatment — OTHER
    SOC per institution

Study Details

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 Dates

Start date
Feb 25, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
2,063 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Single
    Diagnostic testing of sputum sample provided by subject

Primary Outcome Measure

Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum [ Time Frame: From Baseline Sputum Sample provided by subject through 24 months follow up period. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care SystemPalo AltoCalifornia94304
Kalyani Raraviker
[email protected]
650-493-5000
VA Western Colorado Health Care SystemGrand JunctionColorado81501
Lisa Bertrand, RN
[email protected]
970-242-0731
Bay Pines VA Healthcare SystemBay PinesFlorida33744
Sarah Crim, CCRC
[email protected]
727-398-6661
Miami VA Healthcare SystemMiamiFlorida33125
Gregory E. Holt, MD, PhD
[email protected]
305-575-7000
Brian Sturgill, MSN, RN
[email protected]
786-819-0780
Clinical Research Associates of Central PennsylvaniaDuBoisPennsylvania15801
Amber Witherow, RN, BSN
[email protected]
814-661-8837
Audie Murphy VA Medical CenterSan AntonioTexas78234-
Brooke Army Medical CenterSan AntonioTexas78234
Jessica Pedroza, BSN, RN, OCN
[email protected]
210-916-2995

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