NCT07168993 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.
| NCT ID | NCT07168993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | bioAffinity Technologies Inc. |
| Condition | Lung Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,063 participants |
| Start Date | 2026-02-25 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,063 participants in total. It began in 2026-02-25 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Maria Zannes
STUDY CHAIR
bioAffinity Technologies Inc.
Frequently Asked Questions
Who can join the NCT07168993 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Lung Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07168993 currently recruiting?
Yes, NCT07168993 is actively recruiting participants. Contact the research team at xr@bioaffinitytech.com for enrollment information.
Where is the NCT07168993 trial being conducted?
This trial is being conducted at Palo Alto, United States, Grand Junction, United States, Bay Pines, United States, Miami, United States and 3 additional locations.
Who is sponsoring the NCT07168993 clinical trial?
NCT07168993 is sponsored by bioAffinity Technologies Inc.. The principal investigator is Maria Zannes at bioAffinity Technologies Inc.. The trial plans to enroll 2,063 participants.
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