NordICC The Northern-European Initiative on Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95,000
- 试验地点
- 8
- 主要终点
- Comparison of the screening group vs. the control group in an intention-to-treat model after 15 years of follow-up with regard to CRC mortality and CRC incidence
研究概览
简要总结
Colorectal cancer (CRC) is a major burden in western countries. The disease develops from precursor lesions during a long time-interval. Colonoscopy can detect and remove CRC precursor lesions and may thus be effective for CRC prevention. Many national and international health organisations demand evidence from randomised trials to reduce incidence or mortality of the target disease before advocating population-wide cancer screening. However, while colonoscopy screening for the prevention of colorectal cancer is established in the United States and several European countries, no randomised trials exist to quantify the possible benefit of colonoscopy screening. NordICC is a randomised trial investigating the effect of colonoscopy on CRC incidence and mortality.
NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. A minimum of 66 000 individuals, age 55-64 years, are drawn randomly from the population registries in the participating countries. 22 000 are invited for once-only colonoscopy (2:1 randomisation). Expected work-load with 50% compliance will be 11,000 colonoscopies. At the screening examination, all detected lesions are biopsied and removed whenever possible. The remaining 44 000 individuals (control group) are not offered any screening examination (care as usual).The primary study aims are CRC incidence and CRC mortality after 15 years of follow-up, with an interim analysis after 10 years of follow-up. In an intention-to-treat approach, a risk reduction of CRC mortality of 25% in the colonoscopy screening group compared to the control group is expected after 10 years follow-up, estimating 50% compliance in the screening group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study is a population-based randomised controlled trial, with randomisation of individuals age 55-64 years living in the screening areas directly from the Population Registries to either screening group or control group. Eligible persons with the same home address will be randomised to the same group (household randomisation).
排除标准
- •Individuals with previous colorectal surgery (resections, enterostomies)
- •Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
- •On-going cytotoxic treatment or radiotherapy for malignant disease
- •Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
- •Lifelong anticoagulant therapy with Warfarin
- •A coronary event requiring hospitalization during the last 3 months
- •A cerebrovascular event during the last 3 months
- •Resident abroad
- •Return of unopened letter of invitation and/or reminder (address unknown)
- •Message from neighbour/family/post office on death of screenee (not updated in Population Registry)
结局指标
主要结局
Comparison of the screening group vs. the control group in an intention-to-treat model after 15 years of follow-up with regard to CRC mortality and CRC incidence
时间窗: 15 years after screening (interim analysis after 10 years)
次要结局
- CRC mortality and CRC incidence of screening attendees compared to the control group and non-attendees(15 years after screening (interim analysis after 10 years))
- Mortality from all causes(15 years after screening (interim analysis after 10 years))
研究者
Michael Bretthauer
Professor
University of Oslo