A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Non-therapeutic Nerve Conduction Studies
- Non-therapeutic assessment of patient-reported neuropathy
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
7Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)11725, CommackNew York, United States
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Source ClinicalTrials.gov