NCT03140137已完成不适用
Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 5
- 主要终点
- Autoimmune disease flare
研究概览
简要总结
The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Pre-existing autoimmune disease as diagnosed by the physician
- •Immune checkpoint inhibitor therapy for an advanced cancer
排除标准
- •Auto-immune disease developed only after the start of the immune checkpoint inhibitor therapy
- •Absence of follow-up
结局指标
主要结局
Autoimmune disease flare
时间窗: through study completion, an average of 1 year
Increase in the activity of the pre-existing autoimmune disease as assessed by the treating physician
次要结局
- Other immune/inflammatory complications(through study completion, an average of 1 year)
研究者
研究点 (5)
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