EXACT - Understanding immunE-related toXicities by multifACeT Profiling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patients who experience irAEs
研究概览
简要总结
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.
详细描述
The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.
Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.
IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.
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
- •Written informed consent
- •Age 18 years or older
- •Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy
排除标准
- •Medical or psychological condition that would preclude informed consent
- •Planned participation in a drug trial receiving investigational agents
- •Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry.
- •Subjects unable to comply with the study or sample schedule.
结局指标
主要结局
Patients who experience irAEs
时间窗: 36 months
To determine the proportion of patients who experience irAEs during treatment with CPI.
次要结局
- Biological and clinical characteristics(60 months)
- Time to development of irAEs(36 months)
- Proportion of patients experiencing irAEs(60 months)