jRCT1032230396招募中不适用
A multicenter randomized controlled trial to assess the usefulness of computer-aided detection systems for colonoscopy in colorectal cancer screening in the Asia-Pacific region (NCCH2217)
National Cancer Center Hospital, Japan0 个研究点目标入组 1,400 人开始时间: 2023年12月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 50age old over 至 79age old under(—)
- 性别
- All
入选标准
- •Individuals who are scheduled to undergo total colonoscopy for either reason a) or b).
- •a) Primary screening colonoscopy for CRC screening
- •b) Further colonoscopy due to positive fecal immunochemical test (FIT) upon CRC screening
- •Age at entry is between 50 and 79 years.
- •ECOG Performance status is 0 or
- •Written consent to participate in the study has been obtained.
排除标准
- •Individuals with poorly controlled complications (including unstable angina, post-acute myocardial infarction, heart failure, chronic respiratory disease, bleeding tendency) that make it difficult to safely perform colonoscopy.
- •When pathological diagnosis of colorectal lesions is not possible due to reasons such as being on antithrombotic medication and being unable to withdraw the medication
- •Clinically suspicious symptoms of CRC, such as bloody stools or abdominal pain
- •History of CRC treatment
- •History of colorectal surgery involving bowel resection of the colon or rectum (history of surgery not involving bowel resection of the colon or rectum, such as appendectomy for appendicitis, is acceptable)
- •Family history of hereditary CRC
- •Have or have had inflammatory bowel disease
- •Colorectal polyposis
- •Have had a colonoscopy within 5 years before the date of registration
- •Other cases deemed inappropriate by the doctor in charge
结局指标
主要结局
-
Adenoma detection rate (ADR)
次要结局
- Detection rate and number of colorectal neoplastic lesions other than adenomas
- Colonoscopy examination time
研究者
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