Metastatic Renal Cell Carcinoma
Conditions
Keywords
Renal Cell Carcinoma, biomarkers, clinical responses, IO-based therapies, metabolomics, proteomics, Urine
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 informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.
Interventions
No intervention required
Sponsors
National Taiwan University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | 7 years |
| Progression-free survival (PFS) | 7 years |
| Duration of response (DOR) | 7 years |
| Overall survival (OS) | 7 years |
| Adverse event of special interest (AESI) | 7 years |
Countries
Taiwan
Contacts
Primary ContactYeong Shiau Pu, MD PhD
Backup ContactChung Hsin Chen, MD PhD
Outcome results
None listed