NCT05538806招募中不适用
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 23
- 主要终点
- Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.
研究概览
简要总结
The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •≥ 18 years of age
- •Histologically confirmed pleural mesothelioma without any option of curative resection
- •Planned treatment with NovoTTF-200T System according to IFU and medical guidelines
- •Life expectancy more than 3 months at day of enrollment
- •Signed informed consent for use and processing of data
排除标准
- •Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment
结局指标
主要结局
Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.
时间窗: 54 Months
次要结局
- Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.(QoL will be assessed at baseline, 3 and 6 months.)
- Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.(3 years + 18 months follow up)
研究者
研究点 (23)
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