Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA
研究概览
简要总结
The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.
详细描述
A four year prospective non-randomized feasibility implementation study for lung cancer screening in a targeted high-risk population of heavy (ex-)smokers by low-dose CT, combined with a smoking cessation intervention. It will be coordinated by a consortium of researchers from UZA and UAntwerpen.
Lung cancer (LC) remains the leading cause of cancer mortality, worldwide and in Belgium. Prevention and early detection are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation. Besides, other indicators of compliance, quality and turn-around-time will be estimated. It will give insights in the feasibility and potential challenges of implementing a LDCT lung cancer screening program in our region. This implementation project is in line with the European Commission Council recommendation of December 2022 to explore the feasibility and effectiveness of LDCT in a high-risk population. Findings from this study will contribute valuable evidence for policymakers and stakeholders. Furthermore, an implementation pilot is a prerequisite for a future high-quality population-based screening program.
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
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The target population consists of all adult inhabitants from the following municipalities of the ELZ ZORA: Mortsel (2640), Edegem (2650), Boechout (2530), Kontich (2550), Lint (2547), Hove (2540), and having a (TBA) % risk of developing an incidental lung cancer in the following 6 years (calculated a by risk prediction model)
- •Males and females
- •55 -74 years old
- •Fitness for any kind of curative therapy for lung cancer
- •Absence of prior (lung) cancer in the 5 preceding years (excluding skin basal cell carcinoma and early stage cervical cancer)
- •Having a GP or related trusted health care provider
排除标准
- •participant may not have any symptoms (cough, pain when breathing in...)
- •Body weight >140 kg in view of the maximum charge of the CT-scan table
- •The (rare) hereditary Li-Fraumeni syndrome which gives the carriers an excess risk of X-ray induced oncogenesis
研究组 & 干预措施
High-risk (ex-) smokers
Prevention and early detection of lung cancer are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.
干预措施: Low-dose CT scan (Radiation)
High-risk (ex-) smokers
Prevention and early detection of lung cancer are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.
干预措施: Smoking Cessation (Behavioral)
结局指标
主要结局
Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA
时间窗: 2 years
Enrollment rate of eligible responders attending at least one LDCT procedure - Measured by descriptive statistics (discrete data)
次要结局
- Responders(2 years)
- Impact of smoking cessation intervention(2 years)
- Evaluation of shared decision making tool(2 years)
- Number of true and false positive nodules(2 years)
- Success of smoking cessation intervention(2 years)