Urine Omics Predicting IO Therapy Responses in mUC Patients
ConditionMetastatic Urothelial Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age20+
SponsorNational Taiwan University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Advanced and metastatic UC patients who will receive IO-based therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention required
Other interventionNo intervention required
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Cohort A1 intervention
Group B: Cohort B1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Time frame
7 years2
Progression-free survival (PFS)
Time frame
7 years3
Duration of response (DOR)
Time frame
7 years4
Overall survival (OS)
Time frame
7 yearsSponsors and contacts
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Source ClinicalTrials.gov