Urine Omics Predicting IO Therapy Responses in mRCC Patients

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04712305

Collaborator

(none)

400

Enrollment

Location

83.8

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Carcinoma	Other: No intervention required

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 4, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: No intervention required No intervention required
Cohort B Validation cohort will be recruited in the next 36 months of the study period.	Other: No intervention required No intervention required

Arm

Intervention/Treatment

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.

Other: No intervention required

No intervention required

Cohort B

Validation cohort will be recruited in the next 36 months of the study period.

Other: No intervention required

No intervention required

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.