Status:
RECRUITING
Urine Omics Predicting IO Therapy Responses in mRCC Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
20+ years
Brief Summary
The study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving IO-based therapies for metastatic renal cell carcinoma.
Detailed Description
This is a multi-center single-arm translational study where patients with mRCC who are to receive pre-determined IO-based therapy will be invited to participate the study. After signing the approved i...
Eligibility Criteria
Inclusion
- Age \> 20 years
- Subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mRCC)
- Subjects who are about to receive IO-based therapy
- ECOG performance 0, 1, 2, and 3
- Life expectancy \>3 months
- eGFR \> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
- Willing to sign the informed consent form
Exclusion
- Subjects NOT willing to sign the informed consent form
- Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
- 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.
- Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
- Subjects who have taken any IO-based therapy before.
- 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.
Key Trial Info
Start Date :
January 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04712305
Start Date
January 4 2021
End Date
December 31 2027
Last Update
January 20 2022
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100