Clinical trial · Observational
Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy
A Prospective Study Assessing Neurological Function and Its Clinical Implications in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin-Based Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Urothelial Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurological function assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EV-based therapy
- description
- Patients with locally advanced or metastatic urothelial carcinoma receiving enfortumab vedotin-based therapy
- interventionNames
- Diagnostic Test: Neurological function assessment
Primary outcomes (1)
- measure
- Correlation between neurological function and subjective peripheral neuropathy symptoms
- timeFrame
- Baseline to 6 months post-treatment.
- description
- Correlation between objective neurological assessments (nerve conduction study, QST, autonomic function tests, TCNS) and patient-reported peripheral neuropathy symptoms.
Secondary outcomes (1)
- measure
- Correlation between neurological function changes and oncological outcomes
- timeFrame
- From date of EV initiation to the date of death from any cause, assessed up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available