Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

American BioOptics

Status: Unknown

Conditions: Colon Cancer

Treatments: Device: LEBS - Low coherence enhanced backscattering

Study type: Observational

Funder types: Industry

Identifiers

NCT02730702

ABO 2016-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)