Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Colon Cancer Clinical Trial

Official title:

Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02730702
• Other study ID #: ABO 2016-01
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: September 2020

Study information

• Verified date: July 2018
• Source: American BioOptics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Device:
• LEBS - Low coherence enhanced backscattering
Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
American BioOptics, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Radosevich AJ, Mutyal NN, Eshein A, Nguyen TQ, Gould B, Rogers JD, Goldberg MJ, Bianchi LK, Yen EF, Konda V, Rex DK, Van Dam J, Backman V, Roy HK. Rectal Optical Markers for In Vivo Risk Stratification of Premalignant Colorectal Lesions. Clin Cancer Res. 2015 Oct 1;21(19):4347-4355. doi: 10.1158/1078-0432.CCR-15-0136. Epub 2015 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.		Through study completion, an average of 1 year