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.
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)
Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum — From Baseline Sputum Sample provided by subject through 24 months follow up period. Evaluate the clinical performance (positive percent agreement \[PPA/sensitivity\] and negative percent agreement \[NPA/specificity\]) of the FlowPath Lung test in predicting lung cancer from the sputum of high-risk individuals with lung nodules
Trial sites (11)
Facility
City
Region
Status
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
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.
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