Urine Omics Predicting IO Therapy Responses in mRCC Patients

January 18, 2022 updated by: National Taiwan University Hospital

Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Advanced Renal Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Advanced and metastatic RCC patients who will receive IO-based therapy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: 7 years
7 years
Progression-free survival (PFS)
Time Frame: 7 years
7 years
Duration of response (DOR)
Time Frame: 7 years
7 years
Overall survival (OS)
Time Frame: 7 years
7 years
Adverse event of special interest (AESI)
Time Frame: 7 years
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202011088RIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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