Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- The number of cancers detected at stage I
研究概览
简要总结
The aim of this study is to evaluate and optimize entry criteria for the proposed programme for early detection of lung cancer in the Czech Republic.
An estimated 3200 high-risk (age 55-74 years, >30 pack-years) asymptomatic individuals will undergo baseline low-dose chest CT (LDCT) and a follow-up LDCT at 1 year. Patients with poor performance status (PS) 2-4, history of malignancy in the past 10 years, chest CT in the past 1 year, bodyweight >140kg will not be included.
The patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, CT imaging of the thorax, and will undergo spirometry.
Outcomes of the study include:
- optimization of entry criteria, optimization of timing of a follow-up LDCT and management of the patients, proposal of quality assurance indicators
- influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost
- cost-effectiveness of the screening program
- evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)
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
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55-74 years
- •Smoking: >= 30 pack-years, smoker or ex-smoker <15 years
- •Performance status (0-1) - can climb at least one floor without any difficulty or pause
排除标准
- •Body weight above 140 kg
- •Malignant disease within the last 10 years (except non-melanoma skin cancer).
- •Chest CT less than one year ago
- •Clinical signs suspicious of lung cancer (weight loss, new cough, hemoptysis)
结局指标
主要结局
The number of cancers detected at stage I
时间窗: 2023
The proportion of cancers diagnosed at a resectable stage (stage I) vs. non-resectable stage (II-IV) will be compared to the stage distribution in an unscreened population
次要结局
- The cost per diagnosis at a resectable stage(2023)
研究者
Lukas Lambert
Associated professor
General University Hospital, Prague