jRCT2032250010招募中不适用
Laxative-free Colon Examination with AI-powered Radiology Study in Japan (LAXCLEAR Study)
Boston Medical Sciences, Inc.0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 主要终点
- Sensitivity (per-lesion)
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
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 40age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants must be at least 40 years of age at the time of signing the informed consent form (ICF).
- •Participants who tested positive for fecal occult blood within the past year or are suspected of having a colorectal neoplastic lesion and have been deemed by a physician to be candidates for outpatient colonoscopy.
排除标准
- •Confirmed presence of colorectal cancer.
- •Confirmed diagnosis of inflammatory gastrointestinal diseases, such as gastrointestinal ulcers, appendicitis, diverticulitis, or ulcerative colitis.
- •Confirmed diagnosis of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome), based on Amsterdam criteria.
- •Presence of clear risk factors for undergoing colonoscopy.
- •History of colorectal resection.
- •Suspected gastrointestinal stenosis, intestinal obstruction, intestinal perforation, or toxic megacolon.
- •Considered to be at high risk for CT colonography and associated bowel preparation, including but not limited to:
- •Individuals who are unable to follow instructions during the examination due to conditions such as claustrophobia or hearing impairment.
- •Individuals with a history of hypersensitivity to iodine-based or barium-based contrast agents.
结局指标
主要结局
Sensitivity (per-lesion)
for detecting colorectal polyps 6 mm or more on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy serving as the reference standard
次要结局
- Sensitivity and specificity (per-patient) for detecting colorectal polyps 10 mm or more
- Positive predictive value (per-lesion) for colorectal polyps 6 mm or more exceeding 0.72
- Sensitivity and positive predictive value (per-lesion) for colorectal polyps 10 mm or more
- Sensitivity and specificity (per-patient) for detecting colorectal polyps 6 mm or more
研究者
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