Lung Cancer Mutation Consortium Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
研究概览
简要总结
The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subjects (=> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung.
- •Diagnosed May 2012 or later
- •Oral and written informed consent.
排除标准
- •Lung cancer histologies other than adenocarcinoma
- •Lack of adequate tissue.
结局指标
主要结局
Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
时间窗: Five years
The primary objective of this protocol is to determine the frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
Rate of oncogenic mutations in patients with advanced adenocarcinoma of the lung.
时间窗: Five years
The primary endpoint of this protocol is the mutation rate.
次要结局
- Associations between each mutation and clinical outcomes.(Two years)