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.
Purpose
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.
Condition
- Lung Cancer (Diagnosis)
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single |
Diagnostic testing of sputum sample provided by subject |
|
Recruiting Locations
VA Palo Alto Health Care System
Palo Alto, California 94304
Palo Alto, California 94304
VA Western Colorado Health Care System
Grand Junction, Colorado 81501
Grand Junction, Colorado 81501
Bay Pines VA Healthcare System
Bay Pines, Florida 33744
Bay Pines, Florida 33744
Miami VA Healthcare System
Miami, Florida 33125
Miami, Florida 33125
James A. Haley Veterans' Hospital
Tampa, Florida 33612
Tampa, Florida 33612
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois 60064
North Chicago, Illinois 60064
Dayton VA Medical Center
Dayton, Ohio 45428
Dayton, Ohio 45428
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania 15801
DuBois, Pennsylvania 15801
Audie Murphy VA Medical Center
San Antonio, Texas 78234
San Antonio, Texas 78234
Brooke Army Medical Center
San Antonio, Texas 78234
San Antonio, Texas 78234
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- Status
- Recruiting
- Sponsor
- bioAffinity Technologies Inc.
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.