Norwegian Colorectal Cancer Prevention Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100,000
- 试验地点
- 2
- 主要终点
- 1. Evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps).First evaluation after 5 years.
研究概览
简要总结
The purpose of this study is to see if screening with flexible sigmoidoscopy (a flexible viewing tube) may reduce large bowel cancer and cancer deaths. The researchers also want to see if the addition of screening for occult blood in stools may contribute further to this aim. Additionally, the researchers also want to see to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening area and in areas where controlled screening is not established.
详细描述
Although flexible sigmoidoscopy (FS) as a screening tool has a much higher test sensitivity than fecal occult blood tests (FOBT) for colorectal cancer and high-risk adenomas, randomised trials with long-term follow-up are missing. The primary aim is to evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps)
Secondary aims:
- Evaluation of cost/effectiveness of screening for CRC and significant, benign lesions using flex-sig only compared to flex-sig in combination with faecal tests
- To evaluate to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening areas and in areas where controlled screening is not established
- Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk
- Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality
Population:
21,000 men and women, aged 50-64 years, living in the city of Oslo or the county of Telemark are drawn by randomisation (approx. 1:5) from the population registry and invited to have a flexible sigmoidoscopy examination. The control group constitutes 79,000 individuals. Those invited for flexible sigmoidoscopy are further randomised (1:1) to bring or not to bring 3 successive stool samples for FOBT on attendance for FS.
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
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Living in Oslo or Telemark
- •Age 50-64 years
排除标准
- •Patients with previous open colorectal surgery (resections, enterostomies)
- •Individuals in need of long lasting attention and nursing services (somatic or psychosocial reasons, mental retardation)
- •On-going cytotoxic treatment or radiotherapy for malignant disease
- •Severe chronic cardiac or lung disease (NYHA III-IV)
- •Patients with heart valve replacement on life long anticoagulant therapy
- •A coronary event during the last 3 months if having lead to hospitalisation
- •Cerebrovascular accident during the last 3 months
- •Resident abroad
研究组 & 干预措施
A 1 Intervention arm Flex Sig
Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing (Intervention arm A 2). They are drawn directly from the population registry without prior consent to be randomized - approved by Regional Ethics Committees of South-East Norway..
干预措施: A 1 Intervention arm Flex Sig (Procedure)
B Control arm
"No screening group" randomised from population age 50-64 years. As for the active intervention arm, the control group was not informed about being randomized to 'no screening' since 'no screening' was the current usual care (and still is in 2015) in Norway - approved by Regional Ethics Committees of South-East Norway.
A 2 Intervention arm Flex Sig + iFOBT
Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening plus an immunochemical test for fecal occult blood (iFOBT). As for arms A 1 and B, they are drawn directly from the population registry without prior consent to be randomized.
干预措施: A 2 Intervention arm Flex Sig + iFOBT (Procedure)
结局指标
主要结局
1. Evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps).First evaluation after 5 years.
时间窗: Evaluations in 2007 (published),2012,2017
CRC incidence and mortality is followed
次要结局
- 1. Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk. Results "in press" 2005.(Evaluated in 2005 (published))
- 2. Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality. Evaluation in 2005.(Evaluated in 2005 (published))