Urine Omics Predicting IO Therapy Responses in mUC Patients

Last updated: April 15, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

No intervention required

Clinical Study ID

NCT04641936
202010097RINC
  • Ages > 20
  • Male

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 urothelial carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Age > 20 years
    1. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
    1. Subjects who are about to receive IO-based therapy
    1. ECOG performance 0, 1, 2, and 3
    1. Life expectancy 3 months
    1. eGFR > 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
    1. Willing to sign the informed consent form

Exclusion

Exclusion Criteria:

    1. Subjects NOT willing to sign the informed consent form
    1. Subjects with active infection or active urinary tract infection, as shown byurinary WBC > 5/HPF
    1. Subjects having co-existing other malignancies that need active treatment. Thosewith other malignancies that do not need active treatment are allowed to join thestudy.
    1. Subjects taking any immune-modulating agents, including but not limited tocorticosteroid, immune-suppressants, etc. at the discretion of recruitinginvestigators
    1. Subjects who have taken any CPIs before. However, subjects who have receivedintravesical or intrapelvic BCG instillation are allowed to enroll.
    1. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemictherapies within 12 weeks of screening are not allowed. However, subjects who had awashout period of the above agents for >12 weeks are allowed to enroll. Subjects whohave received or are receiving cytotoxic chemotherapy are allowed to join the study.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: No intervention required
Phase:
Study Start date:
December 17, 2020
Estimated Completion Date:
October 31, 2027

Study Description

This is a multi-center single-arm translational study where patients with mUC who are about to receive pre-determined IO-based anti-tumor 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

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.