Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.
研究概览
简要总结
This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).
详细描述
The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance
排除标准
- •personal/family history of colonic neoplasia
- •personal history of coagulopathy
- •(retrospectively) failure to complete or inadequate colonoscopy
- •any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)
结局指标
主要结局
Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点