NCT04708639Enrolling By Invitation不适用
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- mechanism of resistance
研究概览
简要总结
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.
详细描述
The purpose and objectives of the non-interventional study with primary data collection is
- To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
- To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
- To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
- •Written (personally dated and signed) informed consent
排除标准
- 未提供
结局指标
主要结局
mechanism of resistance
时间窗: 15.2 month
ctDNA to establish resistance mechanisms to alectinib treatment
PFS on alectinib
时间窗: 46 month
time from initiation of treatment to progression
次要结局
未报告次要终点
研究者
Peter Meldgaard
MD PhD
Aarhus University Hospital
研究点 (1)
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暂停
2 期
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