Novel Biophotonics Methodology for Colon Cancer Screening

NCT01999478 | Completed

• 1 other identifier: R01CA128641
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 5

Brief Summary

The study is testing a new, safe and effective way for the early detection of colon cancer. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS). This is an optic probe which is a small device that uses light (not laser) to assess the colon lining. This probe will be used before colonoscopy 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 (colon cleaning). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Early cancer changes in the colon

  5 years

Study Arms (1)

Patients undergoing colonoscopy

Patients undergoing colonoscopy per standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be obtained in the gastroenterology clinics.

You may qualify if:

• Patients who have appointments in the GI Clinic and are/or will be scheduled for an colonoscopy as per standard of care.
• Patients must be 18 years of age or older.

You may not qualify if:

• Patients who have a history of Inflammatory Bowel Disease.
• Patients who have colitis.
• Patients who are undergoing chemotherapy.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Northwestern Univeristy

Evanston, Illinois, 60208, United States

Location

University of Indiana

Indianapolis, Indiana, 46202, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Vadim Backman, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Hemant Roy, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BMC Attending Physician

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: February 1, 2008
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 13, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)