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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Urothelial Carcinoma | Participants will have histological or cytologically confirmed urothelial carcinoma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-therapeutic Nerve Conduction Studies | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -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. | up to 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meeting any of the criteria below may not participate in the study:
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Since EV will be given per standard of care, we have not included inclusion criteria relevant to the safety of administering EV itself, since that will be left to the discretion of the treating clinician in a real-world, usual care setting, as is standard practice for non-therapeutic studies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Funt, MD | Contact | 646-888-4770 | funts@mskcc.org | |
| Gopakumar Iyer, MD | Contact | 646-888-4717 |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Funt, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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|
| Non-therapeutic assessment of patient-reported neuropathy | Other | 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 |
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| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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