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.
Recruiting · NCT07168993 · Interventional (participants receive a specific treatment) · Lead sponsor: bioAffinity Technologies Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Standard medical treatment
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.
Who can take part
Age range
50 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Is able to give signed informed consent and comply with study requirements.
- Is high risk for getting lung cancer:
- ≥50 - 80 years of age.
- 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.
- 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.
- a) 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.
- \) 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
- Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
- The dominant nodule is ground glass or part solid as determined by CT scan.
- Has 5 or more nodules sized \>4 mm.
- The nodule sized \>6 to \<30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.
- Is immunosuppressed.
- Has rheumatoid arthritis.
- 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.
- Has angina with minimal exertion.
- Is currently pregnant or planning on becoming pregnant during this study.
Where it is running
11 locations listed across 8 US states.
- VA Palo Alto Health Care System - Palo Alto, California, United States
- VA Western Colorado Health Care System - Grand Junction, Colorado, United States
- Bay Pines VA Healthcare System - Bay Pines, Florida, United States
- Miami VA Healthcare System - Miami, Florida, United States
- James A. Haley Veterans' Hospital - Tampa, Florida, United States
- Captain James A. Lovell Federal Health Care Center - North Chicago, Illinois, United States
- Dayton VA Medical Center - Dayton, Ohio, United States
- Clinical Research Associates of Central Pennsylvania - DuBois, Pennsylvania, United States
- Audie Murphy VA Medical Center - San Antonio, Texas, United States
- Brooke Army Medical Center - San Antonio, Texas, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States