Metastatic Urothelial Carcinoma, Neuropathy, Urothelial Carcinoma
Conditions
Keywords
urothelial carcinoma, metastatic urothelial carcinoma, neuropathy, Memorial Sloan Kettering Cancer Center, 25-371
Brief summary
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
OTHERNon-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
OTHERNon-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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeks | up to 15 weeks | Describe change in Nerve Conduction Studies 9-15 weeks. An NCS measures the flow of electrical current through motor and sensory nerves. The primary outcome will be analyzed as a binary endpoint. Nerve conduction studies measure 9 domains, and if one domain changes from normal to abnormal between baseline and the second timepoint, the patient will be counted as experiencing a worsening neuropathy. |
Countries
United States
Contacts
CONTACTSamuel Funt, MD
CONTACTGopakumar Iyer, MD
PRINCIPAL_INVESTIGATORSamuel Funt, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed