Urine Omics Predicting IO Therapy Responses in mRCC Patients
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2021
CompletedFirst Submitted
Initial submission to the registry
January 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedJanuary 20, 2022
January 1, 2022
5 years
January 13, 2021
January 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
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.
Interventions
Eligibility Criteria
Advanced and metastatic RCC patients who will receive IO-based therapy.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
fresh urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2021
First Posted
January 15, 2021
Study Start
January 4, 2021
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
January 20, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share