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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT03633006
Eligibility Criteria:
Inclusion Criteria:
* All Subjects:
1. Subject is male or female, 35 years of age or older.
2. Subject has at least one CT confirmed 6-30 mm nodule.
3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Suspicion of Cancer Subjects:
4. Subject has CT suspicion of lung cancer and is scheduled for biopsy or other diagnostic procedure.
Pathologically Confirmed Cancer Subjects:
4\. Subject has pathologically confirmed lung cancer and is treatment naïve.
Pulmonary Nodule Subjects:
4\. Subject has a recent (within 90 days of enrollment) CT radiological diagnosis of pulmonary nodule(s) without a scheduled biopsy/diagnostic procedure (other than CT or PET/CT).
Exclusion Criteria:
* All Subjects
1. CT with IV contrast within 1 day \[or 24 hours\] of blood collection.
2. Prior history of cancer within the past 5 years except for non-melanoma skin cancer. For subjects with suspicion of lung cancer who may have a concurrent work-up for another primary cancer, the non-lung cancer primary must be ruled out prior to enrollment.
3. Prior removal of the lung, excluding percutaneous lung biopsy.
4. Treatment (e.g., surgical resection, radiofrequency ablation) for pulmonary nodules prior to blood sample collection for this trial.
5. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Pathologically Confirmed Cancer Subjects:
6. Biopsy within 7 days prior to blood collection.
7. Unresolved bleeding as a result of biopsy at the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT03633006
Study Brief:
Protocol Section:
NCT03633006