Korean Lung Cancer Screening Project for High-risk Smokers to Evaluate Effectiveness and Feasibility of Lung Cancer Screening With Low-dose Computed Tomography for Implementing National Cancer Screening Program
试验速览
- 阶段
- 不适用
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- False positive rate
研究概览
简要总结
Lung cancer is by far the leading cause of cancer death and has a lower relative survival rate than other types of cancer because most lung cancers are detected at an advanced stage when they are first diagnosed.
Recently, a randomized control trial suggests that low-dose computed tomography (LDCT) enables an early stage detection and it has been increasingly accepted as an efficient screening method for high-risk individuals to reduce lung cancer mortality.
In 2011, The National Lung Screening Trial (NLST) in the U.S. has produced results that screening high-risk smoking groups (who have at least 30 pack-year smoking history and currently smoke or have quit within the past 15 years) aged 55 to 74 years with LDCT reduced lung cancer mortality by 20%.
Based on the evidence, Korean National Cancer Center has developed and published the guideline of lung cancer screening using LDCT for high-risk populations in 2015. The guideline recommends annual LDCT screening for high-risk smoking groups aged 55 to 74 years, with at least 30 pack-year smoking history and current smokers or past smokers who quit smoking within 15 years.
The Korean Lung Cancer Screening project (K-LUCAS), a nationwide, multicenter, prospective study started to evaluate the effectiveness and feasibility of lung cancer screening with LDCT for considering implementation of a national lung cancer screening program in Korea.
详细描述
◎ Objective
This study is to evaluate the effectiveness and feasibility of lung cancer screening with LDCT for considering implementation of a national Lung Cancer Screening Program in Korea.
◎ Recruiting procedure
K-LUCAS involves 14 general hospitals located nationwide. The participants in K-LUCAS are recruited from the visitors in these hospitals for receiving national cancer screenings or smoking cessation services. The candidates are evaluated based on the questionnaire that is completed in prior to the national cancer screenings or smoking cessation services. Invitations will be sent to those candidates who meet our selection criteria to take part in LDCT lung cancer screening. Advertising to public including the information both of screening benefit and harm will be held in hospitals, newspaper, local bus stations and subways.
In addition to the criteria-based participant selection, a lung cancer risk prediction model will be adopted to improve the effectiveness of participant selection. The lung cancer risk prediction model considers various lung cancer risk factors in addition to age, smoking history and smoking quit duration which are already examined in the inclusion criteria. The model evaluates drinking amount, physical activity, family history of cancer, past history of lung disease and so on, in participant selection.
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
- 否
入选标准
- 未提供
排除标准
- •Lung cancer diagnosed and treated
- •Inability to move without help (ECOG status 2 or higher)
- •Have been treating regularly for tuberculosis, pneumonia and interstitial lung disease
- •Treated for any cancer within the last 5 years (*Exception: Thyroid cancer, Skin cancer)
- •A chest CT examination less than 6 months
结局指标
主要结局
False positive rate
时间窗: 2 years
Early stage lung cancer detection rate
时间窗: 2 years
Cost-effectiveness of screening
时间窗: 2 years
Lung cancer screening cost per QALY
Complications of diagnostic procedure
时间窗: 2 years
次要结局
- Positve rate of LDCT diagnosis reporting system in Korean population(2 years)
- Effectiveness of quality control of screening units by network-based, computer-aided detection (CAD) system(2 years)
- Participation rate among eligible criteria(2 years)
研究者
Yeol Kim
Principal investigator
National Cancer Center, Korea