Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
bioAffinity Technologies Inc.
Conditions:
Lung Cancer (Diagnosis)
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief 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 Hig...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
2063 Patients enrolled
Trial Details
Trial ID
NCT07168993
Start Date
November 1 2025
End Date
July 1 2029
Last Update
September 11 2025
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