RecruitingNCT04641936
Urine Omics Predicting IO Therapy Responses in mUC Patients
Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
Sponsor
National Taiwan University Hospital
Enrollment
600 participants
Start Date
Dec 17, 2020
Study Type
OBSERVATIONAL
Conditions
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
Sex: MALEMin Age: 20 Years
Inclusion Criteria7
- \. Age > 20 years
- \. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
- \. Subjects who are about to receive IO-based therapy
- \. ECOG performance 0, 1, 2, and 3
- \. Life expectancy 3 months
- \. eGFR > 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
- \. Willing to sign the informed consent form
Exclusion Criteria6
- \. Subjects NOT willing to sign the informed consent form
- \. Subjects with active infection or active urinary tract infection, as shown by urinary WBC > 5/HPF
- \. 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.
- \. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
- \. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
- \. 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.
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Interventions
OTHERNo intervention required
No intervention required
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04641936
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