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.
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)
Do not agree to receive regular neurological examinations
Do not agree to provide complete medical records during treatment
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.
Cohort
Prospective
Neurological function assessment
Diagnostic testNeurological 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.
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.
Correlation between neurological function changes and oncological outcomes
To evaluate whether the degree or pattern of neurological function changes (e.g., worsening in NCS, QST) correlates with clinical efficacy measures such as objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
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