Clinical trial NCT04641936: Urine Omics Predicting IO Therapy Responses in mUC Patients
Official title: Urine Metabolomics and Proteomics Profiling to Predict the Responses and Adverse Events of Immuno-Oncology-based Therapy in Patients With Metastatic Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Urothelial Carcinoma
Keywords: urothelial carcinoma
biomarkers
clinical responses
IO-based therapies
metabolomics
proteomics
Urine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 600
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced and metastatic UC patients who will receive IO-based therapy.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 7 years
measure: Progression-free survival (PFS)
timeFrame: 7 years
measure: Duration of response (DOR)
timeFrame: 7 years
measure: Overall survival (OS)
timeFrame: 7 years
measure: Adverse event of special interest (AESI)
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Urology, National Taiwan University Hospital
name: Yeong Shiau Pu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: