Identifying urine markers to predict responses to immunotherapy in bladder cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with metastatic urothelial carcinoma (mUC) who are about to receive immuno-oncology (IO) therapies. Participants will provide fresh urine samples for analysis using advanced metabolomics and proteomics techniques to identify biomarkers that can predict treatment efficacy and potential side effects. The study aims to enhance personalized treatment approaches by understanding how these urinary markers correlate with patient responses to therapy. It is a multi-center, single-arm study that does not involve any direct interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Yeong Shiau Pu, MD PhD — Department of Urology, National Taiwan University Hospital
• Study coordinator: Yeong Shiau Pu, MD PhD
• Email: pu5249@ntuh.gov.tw
• Phone: 886-2-23123456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.