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.
NCT07168993 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2063
Last updated 2026-03-18
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.
Conditions
- Lung Cancer (Diagnosis)
Interventions
- OTHER
-
Standard medical treatment
Standard of care follow up per institution
- OTHER
-
Standard medical treatment
SOC per institution
Sponsors & Collaborators
-
bioAffinity Technologies Inc.
lead INDUSTRY
Principal Investigators
-
Maria Zannes · bioAffinity Technologies Inc.
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-25
- Primary Completion
- 2029-04-01
- Completion
- 2029-07-01
Countries
- United States
Study Locations
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