Randomized Controlled Trial Evaluating the Efficacy of CAD in Screening Colonoscopy to Reduce the Risk of Advanced Adenoma at 3 Years.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 592
- 试验地点
- 13
- 主要终点
- Advanced adenoma
研究概览
简要总结
The occurrence of interval cancers after colonoscopy raises the possibility of missed lesions. High- performance computer aided diagnosis (CAD) systems have been specially designed for the detection of colorectal lesions (CAD for detection is named CADe). The use of CADe improves adenoma detection in screening colonoscopy. The potential of CADe system in reducing the rate of progression to advanced polyps or interval cancer between two colonoscopies remains still uncertain.
详细描述
Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Randomization into two groups: standard colonoscopy vs. colonoscopy with CADe (CAD EYE or GENIUS) (1:1). A follow-up consultation will be scheduled one-month postcolonoscopy for delivery of histological results and then at 3 years in order to organize the next colonoscopy. As part of the study, a new control colonoscopy will be scheduled for patients with high risk of CRC at 3 years. The 3-year control colonoscopy will be performed with the CAD system for all patients. The colonoscopy will be performed by another investigator who does not know the results nor the type of the first colonoscopy (evaluator blinded). In the low-risk group, we will collect follow-up data as part of routine care, including the results of colonoscopies performed outside of the protocol
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age with indication for colonoscopy as part of a screening program, after a positive immunological (FIT) test, and/or for personal or family history of colorectal cancer and/or personal history of colonic adenomas,
- •Written informed consent signed
- •Patients covered by a health-care insurance.
排除标准
- •Failed complete colonoscopy, defined by the absence of cecal intubation and/or the absence of terminal ileum cauterization
- •Inadequate bowel preparation (Boston bowel preparation score < 6, and/or least at one part of colon with score ≤ 1)
- •An infiltrative tumor was diagnosed during colonoscope insertion time, not accessible to endoscopic resection and likely to require surgical management (a procedure where part of the colon may need to be removed).
- •Patient under guardianship or protection
- •Pregnant women
- •Not fluent in French or illiterate
- •Personal history of inflammatory bowel disease
- •Personal history of genetic predisposition of CRC
- •Personal history of colonic surgery
研究组 & 干预措施
Standard colonoscopy
Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has standard colonoscopy
干预措施: Standard colonoscopy (Procedure)
Colonoscopy with CADe
Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has colonoscopy with CADe (CAD EYE or GENIUS)
干预措施: Colonoscopy CADe (Procedure)
结局指标
主要结局
Advanced adenoma
时间窗: 36 months
The proportion of patients presenting at least one advanced adenoma detected after a 3-year follow-up period. An advanced adenoma is defined as an adenoma or sessile serrate adenoma (SSL) larger than 1cm (size confirmed by the CAD system and/or size estimation by snare), and/or with high-grade dysplasia or neoplasia (confirmed by histological analysis).
次要结局
- Number of adenoma(36 months)
- Estimation of the sensitivity of CADx(Day0, 36 months)
- Estimation of the specificity of CADx(DAY 0, 36 months)
- Cost of CADe and classical colonoscopy(Day 0, 36 months)