Urine Omics Predicting IO Therapy Responses in mUC Patients

Recruiting

• Conditions: Metastatic Urothelial Carcinoma
• Interventions: Other: No intervention required

• Registration Number: NCT04641936
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Study Start: 2020-12-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 600

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	No intervention required	Training cohort will be recruited in the first 24 months of the study period to generate urine metabolomic and proteomic profiles as predictive and prognostic markers.
Cohort B	No intervention required	Validation cohort will be recruited in the next 36 months of the study period.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	7 years
Duration of response (DOR)	7 years
Overall survival (OS)	7 years
Objective Response Rate (ORR)	7 years
Adverse event of special interest (AESI)	7 years

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan