Colonoscopic Biomarkers for Cancer Risk Assessment and Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- number, size, and location of ACF identified
研究概览
简要总结
We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.
详细描述
Subjects are randomly assigned at the time of stain-enhanced magnification colonoscopy to have any ACF removed or merely observed. Subjects are evenly divided into those with and those without a personal history of colon cancer. ACF are tabulated by an observer blinded to the subject's personal history. All subjects are then re-evaluated after one year by an observer blinded to the original procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- 是
入选标准
- •Dept.of Defense Healthcare Beneficiaries
- •Age 18 or over, non-pregnant
- •History of colorectal cancer or other indication for colonoscopic screening
- •At least half of large intestine remaining
- •No use of investigational or chemotherapeutic drugs within 6 mos. -
排除标准
- •History suggesting familial colon cancer syndrome
- •< 6 mos since colon resection or since treatment for colon cancer
- •Anticipated colon surgery within one year of entry
- •Inability to participate in scheduled followup at one year
- •Medical or psychiatric condition which would make patient a poor candidate -
结局指标
主要结局
number, size, and location of ACF identified
时间窗: initially and after one year
次要结局
- complications of stain-enhanced, magnification colonoscopy(initially and after one year)