Immune-Related Rheumatological Adverse Events study (IRRAE study)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 495
- 试验地点
- 4
- 主要终点
- The evaluation of the specific incidence of R-irAE's.
研究概览
简要总结
To collect clinical data on diagnosis and management of R-irAE’s induced by checkpoint inhibitors through prospective data collection of cancer patients in a multicenter setting.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with any oncological disease
- •Starting with ICI therapy (ICI therapy defined as treatment with anti-PD1, anti-PDL1, anti-CTLA-4 or newly registered immune checkpoint therapies, either in mono- or combination therapy)
排除标准
- •Pre-existing rheumatological disease as diagnosed by a rheumatologist.
- •Previous treatment with ICI therapy.
结局指标
主要结局
The evaluation of the specific incidence of R-irAE's.
The evaluation of the specific incidence of R-irAE's.
Serological profiles of patients both with and without preexisting rheumatological disease and starting ICI therapy and those developing R-irAE’s.
Serological profiles of patients both with and without preexisting rheumatological disease and starting ICI therapy and those developing R-irAE’s.
Response to treatment of patients both with and without preexisting rheumatological disease and starting ICI therapy and those developing R-irAE’s.
Response to treatment of patients both with and without preexisting rheumatological disease and starting ICI therapy and those developing R-irAE’s.
次要结局
未报告次要终点
研究者
Principal investigator
Scientific
Stichting Amsterdam UMC