Actively Recruiting
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.
Led by bioAffinity Technologies Inc. · Updated on 2026-03-18
2063
Participants Needed
3
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- Aged between 50 and 80 years
- Current smoker with at least 20 pack-years smoking history or former smoker with at least 20 pack-years who quit within the past 15 years
- Has a lung nodule between 6 and 30 mm in diameter found by CT scan
- Nodule is new, increasing, or stable for 6 months or less
- If multiple nodules, the most suspicious nodule is between 6 and 30 mm
- Willing to provide a sputum sample for FlowPath Lung Test within 6 weeks of baseline CT scan
- Willing to provide contact information for medical follow-up
You will not qualify if you...
- Unable to cough with enough force to produce a sputum sample
- Dominant nodule is ground glass or part solid on CT scan
- Has 5 or more nodules larger than 4 mm
- Nodule is a distal endobronchial or perifissural nodule
- Is immunosuppressed
- Has rheumatoid arthritis
- Had lung cancer in the past 5 years or any other cancer (except non-melanoma skin cancer) in past 2 years
- Has angina with minimal exertion
- Is currently pregnant or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
2
Audie Murphy VA Medical Center
San Antonio, Texas, United States, 78234
Actively Recruiting
3
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Actively Recruiting
Research Team
X
Xavier T Reveles, MS, CG(ASCP)
CONTACT
S
Stacy K Stanek
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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