Urine Omics Predicting IO Therapy Responses in mUC Patients

NCT04641936 | Recruiting

• 1 other identifier: 202010097RINC
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Urothelial Carcinoma

Keywords

urothelial carcinoma; biomarkers; clinical responses; IO-based therapies; metabolomics; proteomics; Urine

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

Cohort B

Validation cohort will be recruited in the next 36 months of the study period.

Other: No intervention required

Interventions

No intervention required OTHER

No intervention required

Cohort A; Cohort B

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \. Age \> 20 years
• \. Subjects diagnosed as metastatic urothelial carcinoma (mUC)
• \. Subjects who are about to receive IO-based therapy
• \. ECOG performance 0, 1, 2, and 3
• \. Life expectancy 3 months
• \. eGFR \> 15 ml/min/1.73 m2 (Stage IV Chronic Kidney Disease or better)
• \. Willing to sign the informed consent form

You may not qualify if:

• \. Subjects NOT willing to sign the informed consent form
• \. Subjects with active infection or active urinary tract infection, as shown by urinary WBC \> 5/HPF
• \. 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.
• \. Subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators
• \. Subjects who have taken any CPIs before. However, subjects who have received intravesical or intrapelvic BCG instillation are allowed to enroll.
• \. 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

fresh urine samples

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yeong Shiau Pu, MD PhD

  Department of Urology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeong Shiau Pu, MD PhD

CONTACT

886-2-23123456; pu5249@ntuh.gov.tw

Chung Hsin Chen, MD PhD

CONTACT

886-2-23123456; mufasachen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: December 17, 2020
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)