Checking nerve function in bladder cancer patients receiving enfortumab vedotin therapy
Studies nerve function and nerve symptoms in adults with advanced urothelial carcinoma on enfortumab vedotin.
Plain-language title generated from the registry record
Registry title: Neurological Function in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin-Based Therapy
Key facts
- Where
- Taipei, TaiwanSee the site
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT07072637
- Record updated
- 18 July 2025
- Original description
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.Read full original descriptionShow less
A Prospective Study Assessing Neurological Function and Its Clinical Implications in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Receiving Enfortumab Vedotin-Based Therapy
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.
Inclusion: 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.
Exclusion: Do not agree to receive regular neurological examinations; Do not agree to provide complete medical records during treatment.