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NCT07168993NARecruiting

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.

bioAffinity Technologies Inc.

Start Date

2/25/2026

Completion Date

7/1/2029

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.

Eligibility Criteria

Age Range: 50 years to 80 years

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.

Interventions

OTHER

Standard medical treatment

OTHER

Standard medical treatment

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Conditions

Lung Cancer (Diagnosis)

Locations

VA Palo Alto Health Care System

Palo Alto, California 94304

United States

VA Western Colorado Health Care System

Grand Junction, Colorado 81501

United States

Bay Pines VA Healthcare System

Bay Pines, Florida 33744

United States

Miami VA Healthcare System

Miami, Florida 33125

United States

James A. Haley Veterans' Hospital

Tampa, Florida 33612

United States

Captain James A. Lovell Federal Health Care Center

North Chicago, Illinois 60064

United States

Dayton VA Medical Center

Dayton, Ohio 45428

United States

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania 15801

United States

Audie Murphy VA Medical Center

San Antonio, Texas 78234

United States

Brooke Army Medical Center

San Antonio, Texas 78234

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States