Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,400
- 试验地点
- 7
- 主要终点
- Detection of advanced lesions
研究概览
简要总结
Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas.
Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect.
The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy.
If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with a positive result in fecal immunochemical test within the population-based colorectal cancer screening program.
- •Complete colonoscopy with cecal intubation.
- •Inform consent signed.
排除标准
- •Personal history of colorectal cancer.
- •Family history of colorectal cancer: ≥2 FDR or ≥1 FDR diagnosed before 50 years of age.
- •Family history of hereditary colorectal cancer syndromes: Lynch syndrome, FAP, etc.
- •Personal history of inflammatory bowel disease.
- •Terminal illness.
- •Personal history of total proctocolectomy.
结局指标
主要结局
Detection of advanced lesions
时间窗: 15 months
To determine the impact of the GI-GENIUS device as an assistant to the endoscopist to detect advanced lesions (advanced adenomas and advanced serrated polyps) in FIT-based screening colonoscopies.
次要结局
- Detection of other type of lesions(15 months)
- Characteristics of GI-GENIUS(1 month)
