NCT07390617招募中不适用
Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic or Muscle-Invasive Urothelial Carcinoma Receiving Enfortumab Vedotin
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Change in Nerve Conduction Studies/NCS from baseline to 12-15 weeks
研究概览
简要总结
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Participants With Urothelial Carcinoma
Participants will have histological or cytologically confirmed urothelial carcinoma
干预措施: Non-therapeutic Nerve Conduction Studies (Other)
Participants With Urothelial Carcinoma
Participants will have histological or cytologically confirmed urothelial carcinoma
干预措施: Non-therapeutic assessment of patient-reported neuropathy (Other)
结局指标
主要结局
Change in Nerve Conduction Studies/NCS from baseline to 12-15 weeks
时间窗: up to 4 months
Describe change in Nerve Conduction Studies/NCS from baseline to 12-15 weeks. An NCS measures the flow of electrical current through motor and sensory nerves.
次要结局
未报告次要终点
研究者
研究点 (7)
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