NCT04641936 Urine Omics Predicting IO Therapy Responses in mUC Patients
| NCT ID | NCT04641936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Metastatic Urothelial Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2020-12-17 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2020-12-17 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Yeong Shiau Pu, MD PhD
PRINCIPAL INVESTIGATOR
Department of Urology, National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT04641936 clinical trial?
This trial is open to male participants only, aged 20 Years or older, studying Metastatic Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04641936 currently recruiting?
Yes, NCT04641936 is actively recruiting participants. Contact the research team at pu5249@ntuh.gov.tw for enrollment information.
Where is the NCT04641936 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT04641936 clinical trial?
NCT04641936 is sponsored by National Taiwan University Hospital. The principal investigator is Yeong Shiau Pu, MD PhD at Department of Urology, National Taiwan University Hospital. The trial plans to enroll 600 participants.