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

NCT ID: NCT07072637

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2031-12-31

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.

Detailed Description

Peripheral neuropathy (PN) is a frequent and often debilitating adverse event associated with enfortumab vedotin (EV), a NECTIN-4-directed antibody-drug conjugate approved for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). While EV has demonstrated significant antitumor efficacy, the objective assessment of PN and its clinical implications remain insufficiently explored. This prospective observational study aims to comprehensively evaluate neurological function and its correlation with subjective PN symptoms in la/mUC patients receiving EV-based therapy.

A total of 100 patients will be prospectively enrolled between March 2025 and December 2029. Neurological assessments will include neurological neurological examination (NE), nerve conduction study (NCS), quantitative sensory testing (QST), autonomic function testing (AFT), and the Toronto Clinical Neuropathy Score (TCNS) questionnaire. These evaluations will be conducted at baseline and every three months until six months post-EV treatment. Clinical data, including patient characteristics and oncologic outcomes, will also be collected.

This study aims to identify predictive factors for EV-related PN and to evaluate the broader clinical implications of neurological function changes. The ultimate goal is to inform strategies for toxicity mitigation and to optimize therapeutic outcomes and quality of life in la/mUC patients.

Conditions

Locally Advanced or Metastatic Urothelial Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EV-based therapy

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

Neurological function assessment

Intervention Type: 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.

Interventions

Neurological function assessment

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 20 y/o

2. Histologically confirmed urothelial carcinoma

3. Radiologically documented locally advanced or metastatic disease

4. Prepare for receiving EV (as monotherapy or in combination with immune checkpoint inhibitors)

5. Complete and identifiable medical records

Exclusion Criteria

1. Do not agree to receive regular neurological examinations

2. Do not agree to provide complete medical records during treatment

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Fu-Jen Hsueh, M.D.

Role: CONTACT

017052@ntuh.gov.tw

02-23123456 ext. 66001

Facility Contacts

Fu-Jen Hsueh, M.D.

Role: primary

017052@ntuh.gov.tw

02-23123456 ext. 66001

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

202502005RINB

Identifier Type: -

Identifier Source: org_study_id