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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-therapeutic Nerve Conduction Studies
Other interventionNon-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
Non-therapeutic assessment of patient-reported neuropathy
Other interventionTo evaluate the incidence and severity of chemotherapy-induced peripheral neuropathy (CIPN) in participants receiving enfortumab vedotin, we will collect non-therapeutic, participant-reported outcomes
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Participants With Urothelial Carcinoma2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 15 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov