Efficacy and Cost-effectiveness of Colonoscopy vs. Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia (eCOLO-FITS): A Randomized Multicenter Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 5,282
- 试验地点
- 2
- 主要终点
- Advanced colorectal adenoma detection rate between two groups
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.
详细描述
The investigators will evaluate the efficacy of FITS for the detection of advanced colorectal neoplasia compared to colonoscopy. This study was designed as multicenter randomized interventional study. The expected period are 36months. A total 13 tertiary hospitals will participate in the study.
Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In colonoscopy group, subjects as a control group would be performed colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic subjects aged 45 - 75 years
- •Subjects who will give the written consent
排除标准
- •Subjects with past history of colorectal cancer
- •Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)
- •Subjects with familial history of colorectal cancer more than 2 familial member in direct line
- •Subjects with inflammatory bowel disease(IBD)
- •Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification
- •Subjects with past history of colectomy
- •Subjects with history of colonoscopy within 5 years
- •Subjects with history of sigmoidoscopy within 3 years
- •Subjects with history of CT colonoscopy within 10 years
- •Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months
结局指标
主要结局
Advanced colorectal adenoma detection rate between two groups
时间窗: on 7 days after intervention
We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.
次要结局
- Sensitivity of fecal immunochemical test for advanced colorectal adenoma(on 7days after intervention)
- Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)
- Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)
- positive predictive valueof fecal immunochemical test for advanced colorectal adenoma(on 7days after intervention)
- specificity of fecal immunochemical test for advanced colorectal adenoma(on 7days after intervention)
- negative predictive value of fecal immunochemical test for advanced colorectal adenoma(on 7days after intervention)
- specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)
- positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)
- negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)
- specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)
- positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)
- negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer(on 7 days after intervention)