A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who Do Not Meet Current Screening Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Lung Cancer Screening
研究概览
简要总结
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.
详细描述
This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.
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
- 40 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 40-82 yrs of age.
- •Presenting for lung cancer screening evaluation.
- •Calculated 6 yr lung cancer risk >1.5% for patients 40-77 years of age or >4% for patients 78-82 years of age.
- •Able and willing to provide informed consent.
排除标准
- •Eligible for clinically indicated lung cancer screening (55-80 yr old, >30 pky smoking history, still smoking or quit smoking within the last 15 yr).
- •Chest CT performed within the last year.
- •Life expectancy less than 6 months.
- •Symptoms clinically consistent with lung cancer.
- •Unable or unwilling to undergo treatment for lung cancer.
- •Any individual who does not give oral and written consent for participation.
结局指标
主要结局
Lung Cancer Screening
时间窗: Duration of the study, up to 3 years
Prospectively identify patients for lung cancer screening using risk calculators
Medical Outcomes
时间窗: Duration of the study, up to 3 years
Evaluate health outcomes of CT screening by assessing the number and stage of lung cancers detected by screening using Lung-RADS criteria
Economic Outcomes
时间窗: Duration of the study, up to 3 years
Evaluate the costs associated with managing lung cancers detected by screening
次要结局
未报告次要终点