Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
- Conditions
- Colon Cancer
- Registration Number
- NCT02730702
- Lead Sponsor
- American BioOptics, LLC
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance
Exclusion Criteria
- age <50
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon. Through study completion, an average of 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States