Different Strategies Using Autoantibodies and/or CT Scan Detection of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,361
- 试验地点
- 2
- 主要终点
- CT alone vs. both Early CDT-Lung test and CT scan.
研究概览
简要总结
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone.
详细描述
In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokers or former smokers
- •At least 20 pack year history of smoking
- •Ages 50 - 75
排除标准
- •Had a CT scan of chest within last 24 months
- •History of any cancer within 10 yrs (except skin cancer or cervical cancer)
- •A serious illness that decreases life expectancy to less than 5 years
- •Any current use of Oxygen
- •Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion
- •Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy
结局指标
主要结局
CT alone vs. both Early CDT-Lung test and CT scan.
时间窗: One year
Assess the number of lung cancers detected with CT alone vs. with both Early CDT-Lung test and CT scan. Compare positive CT results with positive/negative Early CDT Lung test results and assess ability of the combination to detect earlier stage lung cancer.
次要结局
- Value of Early CDT-lung test in detecting cancer(One year)