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.
Sponsored by bioAffinity Technologies Inc.
About this study
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.
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.
Where this study is enrolling (10)
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VA Palo Alto Health Care System
Palo Alto, California
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VA Western Colorado Health Care System
Grand Junction, Colorado
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James A. Haley Veterans' Hospital
Tampa, Florida
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Bay Pines VA Healthcare System
Bay Pines, Florida
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Miami VA Healthcare System
Miami, Florida
Show all 10 locations
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Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois
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Dayton VA Medical Center
Dayton, Ohio
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Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania
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Brooke Army Medical Center
San Antonio, Texas
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Medical College of Wisconsin
Milwaukee, Wisconsin
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.