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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02978118
Eligibility Criteria:
Inclusion Criteria:
Group A Renal Cell Carcinoma:
Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
1. Histologically confirmed or radiological diagnosis of renal cell carcinoma. Clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed.
2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
3. Planned initiation of treatment with any of the following:
* Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
* Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
Group B Urothelial Carcinoma:
Patients will be eligible for inclusion in this study if ALL of the following criteria apply:
1. Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.
2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
3. Planned initiation of treatment with any of the following:
* Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
* Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
1\. History of intercurrent or past condition that would make participation in this protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02978118
Study Brief:
Protocol Section:
NCT02978118