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.
This is a multi-center single-arm translational study where patients with mUC who are about to receive pre-determined IO-based anti-tumor therapy will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via GS-MS/MS and/or LC-MS/MS to identify potential metabolite and protein markers that are able to predict efficacy and side effects of IO-based therapies. All subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of IO-based therapy will be invited and recruited, but those who have received any IO-based therapy before the study can NOT be recruited.
Study Type
OBSERVATIONAL
Enrollment
600
No intervention required
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGObjective Response Rate (ORR)
Time frame: 7 years
Progression-free survival (PFS)
Time frame: 7 years
Duration of response (DOR)
Time frame: 7 years
Overall survival (OS)
Time frame: 7 years
Adverse event of special interest (AESI)
Time frame: 7 years
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