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:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05665504
Eligibility Criteria:
Inclusion Criteria:
* Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer \[clinical stage IA-IB (cT1a-T2aN0), \<4cm diameter\].
* If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
* If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
* \>18 years old, male or female.
* ECOG performance status 0-1.
* Agree to participate in the follow-up protocol.
* Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).
* Ability to understand and the willingness to sign a written, informed consent document.
Exclusion Criteria:
* Participants who are actively receiving any cancer treatment.
* Participants with uncontrolled intercurrent illness.
* Prior lung cancer within 5 years.
* Current active other major cancer except non-melanoma skin cancer.
* Patients with pure ground glass opacities (nodules) or hilar masses.
* Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
* Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
* Patient unable to provide informed consent.
* Prisoner or incarcerated individual.
* For surgical patients, a R1 or R2 resection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05665504
Study Brief:
Protocol Section:
NCT05665504