Urine Tests to Predict Response to Immunotherapy in Metastatic Bladder Cancer
Studies urine markers to see who responds to immunotherapy in advanced urothelial cancer.
Plain-language title generated from the registry record
Registry title: Urine Omics Predicting IO Therapy Responses in mUC Patients
Key facts
- Where
- Taipei, TaiwanSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with metastatic urothelial carcinoma who are about to start immuno-oncology (IO) therapy. Urine tests will be studied to see if they can predict response and side effects.
- Age
- Older than 20 years
- Sex
- Men only
- Disease stage
- Metastatic urothelial carcinoma; ECOG performance status 0, 1, 2 or 3; life expectancy 3 months; eGFR > 15 ml/min/1.73 m2
- Earlier treatment
- Must be about to receive IO-based therapy. Cannot have taken any checkpoint inhibitors (CPIs) before. BCG instilled into the bladder or kidney pelvis is allowed. Cannot have had anti-FGFR therapy, enfortumab vedotin or other systemic therapies within 12 weeks of screening. Earlier cytotoxic chemotherapy is allowed.
Main reasons for not taking part
- Active infection or active urinary tract infection (urinary WBC > 5/HPF)
- Another cancer that needs active treatment
- Taking immune-modulating drugs such as corticosteroids or immune-suppressants
- Any earlier checkpoint inhibitor (CPI) treatment
- Anti-FGFR therapy, enfortumab vedotin or other systemic therapy within 12 weeks of screening
Read by machine on 9 November 2026.
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT04641936
- Record updated
- 17 April 2024
- Original description
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.Read full original descriptionShow less
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
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.
Inclusion: 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: 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; 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; 2. Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF; 1. Subjects NOT willing to sign the informed consent form.