NCT00224601已完成2 期
Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of pre-cancer lesions or early cancer detected.
研究概览
简要总结
The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.
详细描述
Patient with HNPCC syndrome confirmed by a mutation (MLH1, MSH2, MHS1) are involved in the study. Patient have 2 colonoscopy back to back. The second coloscopy is associated to chromoscopy with carmin indigo. Endoscopist are randomised for the colonoscopy with chromoscopy and are un-awarded of the result of the first colonoscopy. Histopathology of the polyp are noted. The follow up were 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with MLH1, MSH2 or MSH6 mutation.
- •Patients concerned by early detection colonoscopy.
排除标准
- •Coloscopy of tracking since less 1an
- •occlusive Syndrome contra-indicating the preparation for a total coloscopies
- •Colectomies
- •medical Conditions or serious illnesses contra-indicating a coloscopy of screening
- •pregnant Woman or nursing
- •Anomaly of coagulation contra-indicating the realization of biopsies and/or the exeresis of the lesion colorectal
结局指标
主要结局
Number of pre-cancer lesions or early cancer detected.
时间窗: during the procedure
次要结局
- Anatomopathologic criteria (size of lesions, …).(during the procedure)
研究者
研究点 (2)
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