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Clinical Trials in the USA / NCT07168993
Recruiting Not applicable

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 · tracked via the Priya Life Science USA tracker
Sponsor
bioAffinity Technologies Inc.
Phase
Not applicable
Started
2026-02-25
Last updated
2026-07-16

Condition(s) studied

Lung Cancer (Diagnosis)

Investigational drug(s) / intervention(s)

Standard medical treatmentStandard medical treatment

Standard medical treatment: Standard of care follow up per institution

Standard medical treatment: SOC per institution

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Is able to give signed informed consent and comply with study requirements. 2. Is high risk for getting lung cancer: 1. ≥50 - 80 years of age. 2. current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years. 3. Has a \>6 to \<30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 6 weeks of the prestudy baseline CT scan. 3a) Nodule is either new, increasing, or stable for ≤ 6 months. 3b) In cases where a person has multiple nodules as determined by CT scan, the subject's most suspicious nodule is \>6 to \<30 mm in diameter. 4\) Is willing to provide contact information to the study PI or the treating physician(s) who can release required medical information related to SOC follow-up. Exclusion Criteria: 1. Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease). 2. The dominant nodule is ground glass or part solid as determined by CT scan. 3. Has 5 or more nodules sized \>4 mm. 4. The nodule sized \>6 to \<30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule. 5. Is immunosuppressed. 6. Has rheumatoid arthritis. 7. Had lung cancer diagnosis in the past 5 years or any other cancer (other than non-melanoma skin cancer) in the past 2 years. A subject on long-term medications used for prevention of cancer, such as Tamoxifen for breast cancer, is not excluded. 8. Has angina with minimal exertion. 9. Is currently pregnant or planning on becoming pregnant during this study.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
VA Palo Alto Health Care System Palo Alto California Recruiting
VA Western Colorado Health Care System Grand Junction Colorado Recruiting
Bay Pines VA Healthcare System Bay Pines Florida Recruiting
Miami VA Healthcare System Miami Florida Recruiting
James A. Haley Veterans' Hospital Tampa Florida Recruiting
Captain James A. Lovell Federal Health Care Center North Chicago Illinois Recruiting
Dayton VA Medical Center Dayton Ohio Recruiting
Clinical Research Associates of Central Pennsylvania DuBois Pennsylvania Recruiting
Audie Murphy VA Medical Center San Antonio Texas Recruiting
Brooke Army Medical Center San Antonio Texas Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting

More bioAffinity Technologies Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07168993 on ClinicalTrials.gov ↗ ← All trials in the USA