Assessing the Effectiveness of Low-Dose Computed Tomography in Lung Cancer Screening for High-Risk Smokers: A Randomized Controlled Trial in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Lung cancer mortality
研究概览
简要总结
The investigators propose a randomized controlled trial to evaluate the clinical effectiveness of low-dose computed tomography (LDCT) for lung cancer screening in high-risk Chinese ever-smokers aged 50-79 years in Hong Kong and to assess the cost-effectiveness of implementing LDCT for lung cancer screening in the local setting.
详细描述
Background:
Lung cancer is an important public health problem in Hong Kong and worldwide. In Hong Kong, lung cancer always ranked the top in terms of incidence and mortality among common cancers in both sexes. Previous studies has suggested that cancer screening could potentially achieve a stage shift that enables the diagnosis of more cancer cases in early-stages (I or II), thereby enabling earlier treatment of early-stage cancers rather than advanced-stage cancers to achieve higher survival rates and reduction in the overall mortality. In particular, low-dose computed tomography (LDCT) was reported to be effective in screening for lung cancer among smokers in some countries. However, given the vast difference in smoking prevalence, lung cancer incidence and staging pattern at presentation, findings regarding both benefits and harms from one population may not be directly applicable to other populations. This highlights the importance of local evidence on both clinical effectiveness and cost-effectiveness of LDCT lung cancer screening in Hong Kong.
Aim:
To implement LDCT screening for high-risk ever-smokers to generate local data and robust evidence on the clinical effectiveness, cost-effectiveness, and feasibility of LDCT screening.
Study Design and overview:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 50 and 79 years
- •Current smokers or ex-smokers quitted for less than 10 years, with a history of cigarette smoking equivalent to at least 20 pack-years
排除标准
- •Non-Chinese population
- •Individuals who are not mentally competent to provide informed consent (e.g., those with a history of dementia)
- •Individuals with a known prior diagnosis of lung cancer or detection of lung nodules
- •Individuals with a history of other cancers within the last five years or currently under treatment
- •Individuals who have undergone a CT scan of the thorax in the previous 12 months
- •Individuals who are either unwilling to undergo a chest LDCT scan, or having a condition that prevents them from having a LDCT scan (for example, pregnancy or inability to lie flat on the CT table)
研究组 & 干预措施
CONTROL arm
CONTROL arm: No LDCT screening
SCREEN Arm
SCREEN Arm: 3 rounds of LDCT screening performed at the baseline (T0), 18 ± 3 months (T1), 42 ± 3 months (T2) from baseline
干预措施: Low-dose computed tomography (LDCT) (Diagnostic Test)
结局指标
主要结局
Lung cancer mortality
时间窗: 10 years
Defined as the lung cancer-related death. The survival status of diagnosed lung cancer patients in both arms will be reviewed yearly after the first five years up to 10 years through Hospital Authority of Hong Kong (HA)'s Data Sharing Portal services or the Deaths Registry, supplemented by access to Clinical Management System (CMS) if needed. The lung cancer mortality rate will be calculated by dividing (a) the number of lung cancer-related deaths by (b) the number of person-years.
次要结局
- Stage distribution of lung cancer cases(10 years)
- Lung cancer incidence(10 years)
- Prevalence of false-positive of screening cases(10 years)
- Percentage of overdiagnosis of lung cancer cases(10 years)
- Prevalence of radiation-induced cancers(10 years)
- Health-related quality of life (HRQoL)(10 years)
研究者
Prof Dennis Kai-Ming Ip
Clinical Associate Professor
The University of Hong Kong