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

NCT07072637 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-07-18

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2030-12-31
Completion
2031-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07072637 on ClinicalTrials.gov