NCT07168993

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.

Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,063 (estimated)
• Sponsor: bioAffinity Technologies Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Lung Cancer (Diagnosis)

Interventions

Type	Name	Description
OTHER	Standard medical treatment	Standard of care follow up per institution
OTHER	Standard medical treatment	SOC per institution

Timeline

• Start date: 2026-02-25
• Primary completion: 2029-04-01
• Completion: 2029-07-01
• First posted: 2025-09-11
• Last updated: 2026-03-18

Locations

3 sites across 1 country: United States