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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT05254132
Eligibility Criteria:
Inclusion Criteria:
* Participant must be aged at least 18 years
* Willing and able to comply with clinic visits and study-related procedures.
* Willing and able to provide signed informed consent.
* Participant must be at first diagnosis of NSCLC and have the largest diameter of the primary tumor equal or greater than 2 cm.
* Participant must be treatment naïve (includes radiotherapy).
* Participant must have received a CT scan for the diagnosis of NSCLC according to "Imaging Protocol" document (Appendix 1).
* Participant with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or ≥25 unstained slides (at least 10 unstained slides). Participant without adequate archival tumor specimens cannot be included
Additional inclusion criteria specific to aRECIST cohort:
* Participant must be diagnosed with NSCLC Stage IV.
* Participant must have a life expectancy ≥ 3 months.
* Participant must have at least one lesion that is suitable for accurate repeated assessment (according to RECIST criteria).
* Participant must be able to comply with standard of care visits for imaging purposes to follow-up on treatment response.
* Participant must need to agree to undergo a liquid biopsy at baseline and at follow-up visits.
* Participant must undergo either chemotherapy or immunotherapy after baseline visit, according to SoC.
Exclusion Criteria:
* Pregnant or breast-feeding participants (to avoid radiation exposure)
* Participant is either an employee of Radiomics or the investigational center or an immediate relative of an employee of Radiomics or the investigational center.
* Participant with total body CT scan already performed at a different site with acquisition parameters different from those reported in the Imaging Protocol
Additional inclusion criteria specific to aRECIST cohort:
• Participant who previously underwent or are planned for curable cancer surgery (lobectomy, wedge resection, pneumonectomy) or ablative radiotherapy on metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05254132
Study Brief:
Protocol Section:
NCT05254132