Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy

NCT07072637 | Not Yet Recruiting

• 1 other identifier: 202502005RINB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate the correlation between neurological function and patient-reported symptoms of peripheral neuropathy (PN) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) receiving enfortumab vedotin (EV)-based therapy. A total of 100 patients will be enrolled between March 2025 and December 2029. Eligible participants will undergo comprehensive neurological assessments, including neurological examination(NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These assessments will be conducted at baseline and every three months until six months after completion of EV-based therapy. Patient characteristics and oncological outcomes will also be collected. This study seeks to identify risk factors for developing PN and to explore the clinical implications of EV-associated neurological changes, with the ultimate goal of optimizing treatment strategies and improving quality of life.

Conditions

Locally Advanced or Metastatic Urothelial Carcinoma

Keywords

enfortumab vedotin; urothelial carcinoma; neurological function

Outcome Measures

Primary Outcomes (1)

• Correlation between neurological function and subjective peripheral neuropathy symptoms

  Correlation between objective neurological assessments (nerve conduction study, QST, autonomic function tests, TCNS) and patient-reported peripheral neuropathy symptoms.

  Baseline to 6 months post-treatment.

Secondary Outcomes (1)

• Correlation between neurological function changes and oncological outcomes

  From date of EV initiation to the date of death from any cause, assessed up to 36 months

Study Arms (1)

EV-based therapy

Patients with locally advanced or metastatic urothelial carcinoma receiving enfortumab vedotin-based therapy

Diagnostic Test: Neurological function assessment

Interventions

Neurological function assessment DIAGNOSTIC_TEST

Neurological evaluations including neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. Assessments will be conducted at baseline and every three months until six months after completion of EV treatment.

EV-based therapy

Eligibility Criteria

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

Study Population

Adult patients (age ≥ 20 years) with histologically confirmed locally advanced or metastatic urothelial carcinoma who are planned to receive EV-based therapy. Participants must be eligible for neurological assessments and able to provide informed consent.

You may qualify if:

• Age ≥ 20 y/o
• Histologically confirmed urothelial carcinoma
• Radiologically documented locally advanced or metastatic disease
• Prepare for receiving EV (as monotherapy or in combination with immune checkpoint inhibitors)
• Complete and identifiable medical records

You may not qualify if:

• Do not agree to receive regular neurological examinations
• Do not agree to provide complete medical records during treatment

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fu-Jen Hsueh, M.D.

CONTACT

02-23123456; 017052@ntuh.gov.tw

Study Design

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

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)