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临床试验/NCT04031963
NCT04031963已完成不适用

Novel Biophotonics Methodology for Colon Cancer Screening

NorthShore University HealthSystem1 个研究点 分布在 1 个国家目标入组 857 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
857
试验地点
1
主要终点
Early cancer changes in the colon

研究概览

简要总结

This is a proposal to establish a Bioengineering Research Partnership (BRP). The major objective of the BRP is to refine and provide comprehensive, definitive multi-center validation of these novel methodologies for colorectal cancer (CRC) screening, thus providing a quantum leap in population screening.

详细描述

Background and Significance highlights the impracticality to provide total colonic evaluation for the entire population. Risk-stratification via exploitation of the "field effect" is an attractive approach. However, all existing methodologies (e.g FOBT, fecal DNA, flexible sigmoidoscopy) are clearly suboptimal underscoring the need for novel tools for identifying the field effect.

  1. We have developed ELF/LEBS for depth-selective (from ~30 to hundreds of microns) spectroscopic assessment of living tissue. 2) We tested these novel techniques in two animal models of CRC (the AOM-treated rat and MIN-mouse) and in human subjects (n=190). We demonstrated that ELF/LEBS has the potential to detect precancerous changes in the colon at a time point that precedes the formation of adenomas and other histological/molecular markers of CRC. 3) We demonstrated that rectal ELF/LEBS can detect field effect alterations in histologically normal rectal tissue changes due to the presence of adenomas anywhere in the colon. In our pilot studies, the diagnostic accuracy of rectal ELF/LEBS far exceeded any other currently known markers of CRC. Therefore, assaying ELF/LEBS in the rectum has the potential to provide accurate risk-stratification for colon carcinogenesis without the need for bowel preparation and colonoscopy. 4) We have developed prototypes of ELF and LEBS fiber-optics probes for in vivo use.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject is 18 years old or older and is having a colonoscopy procedure.

排除标准

  • Concurrent usage of anticoagulation or blood thinner medication within the last 7 days that would preclude Hx of Inflammatory Bowel Disease/Colitis/Chemotherapy.

结局指标

主要结局

Early cancer changes in the colon

时间窗: Visit 1, screening colonoscopy

ELF/LEBS probe used to obtain spectroscopy readings from rectal tissue

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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