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Recruiting NCT04641936

Urine Omics Predicting IO Therapy Responses in mUC Patients

— Observational Metastatic Urothelial Carcinoma

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 Urothelial Carcinoma. Basic parameters: from 20 years · Male.
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 Metastatic Urothelial 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 urothelial carcinoma.

Detailed 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.

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

  • 1\. Age > 20 years
  • 2\. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
  • 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 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 CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
  • 6\. Subjects who have received anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening are not allowed. However, subjects who had a washout period of the above agents for >12 weeks are allowed to enroll. Subjects who have received or are receiving cytotoxic chemotherapy 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: NCT04641936 · 202010097RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗