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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT03955393
Eligibility Criteria:
Inclusion Criteria:
* age of at least 18 years with diagnosis of RCC;
* patients candidates to radical nephrectomy and extended lymphadenectomy
* clinical T4 cancers or renal masses with evidence of lymphadenopathies at preoperative CT scan or larger tumor (max diameter\>10 cm)
* performance status 0-1;
* expected survival time of at least 3 months;
* recovery from toxic effects of any previous treatment;
* serum biochemical and haematological measurements within healthy parameters.
* Female patients of childbearing age were requested to have a negative pregnancy test
* ability to understand and understand informed consent
* acceptance and signature of informed consent
Exclusion Criteria:
* other medical conditions that might limit the amount of antibody to be administered;
* New York Heart Association Class III/IV cardiac disease;
* pregnancy and breastfeeding
* eGFR\<30;
* women of child-bearing age who do not agree to use contraceptives to avoid pregnancy;
* history of autoimmune hepatitis;
* allergy to iodine;
* unavailability or immunological and clinical follow-up assessments;
* participation in another clinical trial involving an investigational agent within 4 weeks of study enrolment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03955393
Study Brief:
Protocol Section:
NCT03955393