Electroporation for Cancer Treatment Real World Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (CTCAE)
研究概览
简要总结
This registry aims to assess real-world long-term disease outcomes for patients treated using reversible electroporation and a chemotherapeutic or calcium; in particular tumour response rates and recurrence rates. The study also aims to characterise side effects and the occurrence of Adverse Events and their relationship to the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient who has been treated using Calcium Electroporation
- •Any patient who has been treated using Electrochemotherapy
- •Patients must be mentally capable of understanding the information given
- •Patients must give written informed consent.
排除标准
- 未提供
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (CTCAE)
时间窗: 5 years
Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
- Response Evaluation Criteria in Solid Tumours (RECIST)(3 months, 12 months, 3 years, 5 years)