Census and Follow-up of the Side Effects in the New Immunotherapeutic Treatments Anti-PD-(L)-1 and Anti-CTLA-4 of the Non Small Cells Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Census and monitor of the side-effects due to the immunotherapy treatment.
研究概览
简要总结
The immune-related adverse events (irAEs) linked to the important activation of the immune system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma (NSCLC) have not received a lot of systematic study or been monitored over time outside of clinical trials.
This study aims to verify, on the basis of the data collected in a prospective and retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments observed in the target population of the controlled clinical trials are the same as in the general clinical population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy in first or second line.
排除标准
- •The refusal to sign the consent.
结局指标
主要结局
Census and monitor of the side-effects due to the immunotherapy treatment.
时间窗: Through study completion, an average of 20 months.
Census of the side-effect type, severity according to the CTCAE and monitoring the side-effect's development.
次要结局
未报告次要终点
研究者
Alexandre Niset
Med student
Cliniques universitaires Saint-Luc- Université Catholique de Louvain