Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Yeong Shiau Pu, MD PhD
pu5249@ntuh.gov.tw
886-2-23123456
Backup
Chung Hsin Chen, MD PhD
mufasachen@gmail.com
886-2-23123456
Time Frame
Start Date: 2021-01-04
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 400
Treatments
Cohort A
Training cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers.
Cohort B
Validation cohort will be recruited in the next 36 months of the study period.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital