Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Proportion of enrolled patients who attend for their assigned screening test
研究概览
简要总结
Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from colon cancer. A large study comparing these three tests is desperately needed. In this pilot study, the investigators want to find out what percentage of patients will show up for their screening test once enrolled. This will provide crucial information for the successful execution of the larger study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All individuals age 50 to 70 years
排除标准
- •Unable to give informed consent
- •History of colorectal cancer
- •History of adenomatous polyp
- •History of inflammatory bowel disease
- •Prior participation in FOBT screening
- •Prior refusal to participate in FOBT screening
- •Flexible sigmoidoscopy within the previous 3 years
- •Virtual colonoscopy within the previous 3 years
- •Optical colonoscopy within the previous 3 years
- •Severe of terminal illness that would preclude benefit from colon cancer screening
结局指标
主要结局
Proportion of enrolled patients who attend for their assigned screening test
时间窗: Immediate
次要结局
- Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.(Immediate)
- Proportion of patients found to have an advanced adenoma(6 months)
- Proportion of patients found to have invasive colorectal carcinoma(6 months)
- Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy(6 months)
- Proportion of subjects who cross over to another arm of the study(6 months)
研究者
John You
Assistant Professor
McMaster University