Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT07168993
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT07168993
Study Brief:
Protocol Section:
NCT07168993