Urine Omics Predicting IO Therapy Responses in mUC Patients
Recruiting now
Conditions studied: Metastatic Urothelial Carcinoma
In brief
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.
Key facts
- Study ID
- NCT04641936
- Run by
- National Taiwan University Hospital
- People needed
- 600
- Starts
- 2020-12-17
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2024-04-17
Who can join
Age: 20 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.