Recruiting NCT07390617
A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-therapeutic Nerve Conduction Studies, Non-therapeutic assessment of patient-reported neuropathy.
- Who it may be relevant to
- Registry conditions: Neuropathy, Urothelial Carcinoma, Metastatic Urothelial Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic or Muscle-Invasive Urothelial Carcinoma Receiving Enfortumab Vedotin
Overview
The purpose of this study is to see how results of nerve tests change in people with urothelial cancer who receive treatment with enfortumab vedotin (EV)
Interventions
- Other Non-therapeutic Nerve Conduction Studies
Non-invasive nerve conduction studies (NCS) offer an objective, quantitative approach to assess peripheral nerve function, particularly in sensory fibers, which are most commonly affected in chemotherapy-induced peripheral neuropathy/CIPN - Other Non-therapeutic assessment of patient-reported neuropathy
To evaluate the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) in participants receiving enfortumab vedotin, we will collect non-therapeutic, participant-reported outcomes
Primary outcome measures
- Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeks [Time frame: up to 15 weeks]
Eligibility criteria
Inclusion criteria
- Written informed consent by and HIPAA authorization for release of personal health information obtained from the research participant.
- Able to speak and read English to a sufficient level of fluency to provide informed consent and complete the study questionnaires.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of ≤ 3 within 28 days prior to consent.
- Histological or cytologically confirmed urothelial carcinoma.
- Patients must be planned to start systemic therapy with enfortumab vedotin
- At time of enrollment, patients must be planned to start enfortumab with or without pembrolizumab
Exclusion criteria
Subjects meeting any of the criteria below may not participate in the study:
- Inability of the subject to understand and comply with study procedures.
- Having previously received enfortumab vedotin
- Students/employees of the study institution, pregnant women, prisoners, and institutionalized individuals (to prevent enrollment of vulnerable subjects).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre
Identifiers
NCT: NCT07390617 · 25-371