Urine Omics Predicting IO Therapy Responses in mRCC Patients

Last updated: January 18, 2022
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT04712305
202011088RIN
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 urinaryWBC > 5/HPF
  3. Subjects having co-existing other malignancies that need active treatment. Thosesubjects with other malignancies that do not need active treatment are allowed to jointhe study.
  4. Subjects taking any immune-modulating agents, including but not limited tocorticosteroid, immune-suppressants, etc. at the discretion of recruitinginvestigators
  5. Subjects who have taken any IO-based therapy before.
  6. Subjects who have received other systemic anti-cancer therapies within 4 weeks ofscreening are not allowed. However, subjects who had a washout period of the aboveagents for >4 weeks are allowed to enroll. Subjects who have received or are receivingtargeted therapy are allowed to join the study.

Study Design

Total Participants: 400
Study Start date:
January 04, 2021
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

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