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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT04712305
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 20 years
2. Subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mRCC)
3. Subjects who are about to receive IO-based therapy
4. ECOG performance 0, 1, 2, and 3
5. Life expectancy \>3 months
6. eGFR \> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
7. Willing to sign the informed consent form
Exclusion Criteria:
1. Subjects NOT willing to sign the informed consent form
2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
3. Subjects having co-existing other malignancies that need active treatment. Those subjects with other malignancies that do not need active treatment are allowed to join the study.
4. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
5. Subjects who have taken any IO-based therapy before.
6. Subjects who have received other systemic anti-cancer therapies within 4 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for \>4 weeks are allowed to enroll. Subjects who have received or are receiving targeted therapy are allowed to join the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04712305
Study Brief:
Protocol Section:
NCT04712305