Validation of a Multi-gene Test for Lung Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 403
- 试验地点
- 13
- 主要终点
- Accuracy of LCRT to predict incidental lung cancer
研究概览
简要总结
The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.
详细描述
Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 or more pack year smoking history
- •clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy
排除标准
- •Lung Cancer within 3 months after the date of enrollment
结局指标
主要结局
Accuracy of LCRT to predict incidental lung cancer
时间窗: from time of enrollment
Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT).
次要结局
未报告次要终点