Urine Omics Predicting IO Therapy Responses in mUC Patients

Metastatic Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641936
• Other study ID #: 202010097RINC
• Status: Recruiting
• Start date: December 17, 2020
• Est. completion date: October 31, 2027

Study information

• Verified date: April 2024
• Source: National Taiwan University Hospital
• Contact: Yeong Shiau Pu, MD PhD
• Phone: 886-2-23123456
• Email: pu5249[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Metastatic Urothelial Carcinoma

Intervention

Other:
• No intervention required
No intervention required

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		7 years
Primary	Progression-free survival (PFS)		7 years
Primary	Duration of response (DOR)		7 years
Primary	Overall survival (OS)		7 years
Primary	Adverse event of special interest (AESI)		7 years