Comparison Between Faecal Occult Blood Test (FOBT), Computed Tomographic Colonography (CTC) With Computer Aided Diagnosis (CAD) and Colonoscopy as a Primary Screening Test for Colorectal Cancer. Validation of a Teleradiology Model. Biological Banking in Subjects Recruited for Colonoscopy or CTC.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16,087
- 试验地点
- 2
- 主要终点
- Detection rate for cancer or advanced adenomas of CTC versus three rounds of FOBT every second year
研究概览
简要总结
RATIONALE: Computed tomographic colonography (CTC) has proven to be accurate in detecting colorectal neoplasms and may be a primary test in colorectal cancer screening.
PURPOSE: This clinical trial will compare participation rate, diagnostic yield and costs of computed tomographic colonography, faecal occult blood test (FOBT) and colonoscopy (CO) as a primary screening test in a population-based programme.
详细描述
OBJECTIVES:
Primary objectives:
- To compare the participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy (CO) as a primary screening test in a population-based programme for colorectal cancer.
- To compare the participation rate to CTC with reduced cathartic preparation versus CTC with standard bowel preparation.
- To compare the detection rate for cancer or advanced adenomas of CTC with computer aided diagnosis (CAD) versus three rounds of FOBT every second year.
- To evaluate referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year.
- To compare costs of the three screening strategies.
Secondary objectives:
- To compare the expected and perceived discomfort of colonoscopy and computed tomographic colonography as assessed with a structured questionnaire.
- To evaluate the rate of complications in each group.
- To validate a teleradiology model for computed tomographic colonography.
- To create a biological bank of blood and stool specimens from subjects who undergo computed tomographic colonography, primary colonoscopy and second level colonoscopy.
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
- 55 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Never invited to previous colorectal cancer screening.
排除标准
- •Personal history of colorectal cancer or colonic advanced adenomas.
- •Inflammatory bowel disease (IBD).
- •Previous five years complete colonoscopy or previous two years faecal occult blood test (FOBT).
研究组 & 干预措施
Computed tomographic colonography (CTC), reduced prep
Subjects invited to undergo CTC with reduced cathartic preparation
干预措施: Invitation to screening (Other)
Computed tomographic colonography (CTC), standard prep
Subjects invited to undergo CTC with standard bowel preparation
干预措施: Invitation to screening (Other)
Faecal occult blood test (FOBT)
Subjects invited to undergo FOBT
干预措施: Invitation to screening (Other)
Colonoscopy
Subjects invited to undergo colonoscopy
干预措施: Invitation to screening (Other)
结局指标
主要结局
Detection rate for cancer or advanced adenomas of CTC versus three rounds of FOBT every second year
时间窗: 6 years
Costs of the three different screening strategies proposed
时间窗: 6 years
Participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy
时间窗: 2 years
Referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year
时间窗: 6 years
次要结局
- Expected and perceived burden of colonoscopy and CTC(2 years)
- Number and type of complications in all groups(2 years)