Urine Omics Predicting IO Therapy Responses in mRCC Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention required.
- Who it may be relevant to
- Registry conditions: Metastatic Renal Cell Carcinoma. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma
Overview
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
- Other No intervention required
No intervention required
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: 7 years]
- Progression-free survival (PFS) [Time frame: 7 years]
- Duration of response (DOR) [Time frame: 7 years]
- Overall survival (OS) [Time frame: 7 years]
- Adverse event of special interest (AESI) [Time frame: 7 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT04712305 · 202011088RIN