Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon. [Through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance
Exclusion Criteria:
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age <50
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personal/family history of colonic neoplasia
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personal history of coagulopathy
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(retrospectively) failure to complete or inadequate colonoscopy
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any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
Sponsors and Collaborators
- American BioOptics, LLC
Investigators
- Principal Investigator: The Quyen Nguyen, Ph.D., American BioOptics
Study Documents (Full-Text)
None provided.More Information
Publications
- ABO 2016-01