Actively Recruiting
Urine Omics Predicting IO Therapy Responses in mUC Patients
Led by National Taiwan University Hospital · Updated on 2024-04-17
600
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Urine Omics Predicting IO Therapy Responses in mUC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
Y
Yeong Shiau Pu, MD PhD
CONTACT
C
Chung Hsin Chen, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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