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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.

NCT07168993 · bioAffinity Technologies Inc.
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Official title
Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 2063 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-02-25
Estimated completion: 2029-07-01
Last updated: 2026-03-18
Interventions
Other: Standard medical treatmentOther: Standard medical treatment
Primary outcomes
  • 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.)
Sponsor
bioAffinity Technologies Inc. · industry
Contacts & investigators
ContactXavier T Reveles, MS, CG(ASCP) · contact · xr@bioaffinitytech.com · 210-698-5334
ContactStacy K Stanek · contact · stacy.stanek@harvestiro.com · 612-716-7666
InvestigatorMaria Zannes · study_chair, bioAffinity Technologies Inc.
All locations (3)
Clinical Research Associates of Central PennsylvaniaRecruiting
DuBois, Pennsylvania, United States
Audie Murphy VA Medical CenterRecruiting
San Antonio, Texas, United States
Brooke Army Medical CenterRecruiting
San Antonio, Texas, United States
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. · TrialPath