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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Urothelial Carcinoma
• Intervention / Treatment: Other: No intervention required

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Yeong Shiau Pu, MD PhD; Phone Number: 65254 886-2-23123456; Email: pu5249@ntuh.gov.tw
• Study Contact Backup: Name: Chung Hsin Chen, MD PhD; Phone Number: 65242 886-2-23123456; Email: mufasachen@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yeong-Shiau Pu, MD PhD; Phone Number: 65254 886-2-23123456; Email: pu5249@ntuh.gov.tw
    • Contact: Chung-Hsin Chen, MD PhD; Phone Number: 65242 886-2-23123456; Email: mufasachen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Advanced and metastatic UC patients who will receive IO-based therapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; 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.	Other: No intervention required; No intervention required
Cohort B; Validation cohort will be recruited in the next 36 months of the study period.	Other: No intervention required; No intervention required

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yeong Shiau Pu, MD PhD, Department of Urology, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; Urine; urothelial carcinoma; metabolomics; proteomics; clinical responses; IO-based therapies
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: 202010097RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No