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
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.