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Novel Biophotonics Methodology for Colon Cancer Screening (BRP)

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ClinicalTrials.gov Identifier: NCT01999478
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Hemant Kumar Roy, Boston Medical Center

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.

Condition or disease
Colon Cancer

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Biophotonics Methodology for Colon Cancer Screening
Study Start Date : February 2008
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
Patients undergoing colonoscopy
Patients undergoing colonoscopy per standard of care.



Primary Outcome Measures :
  1. Early cancer changes in the colon [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be obtained in the gastroenterology clinics.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999478


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Northwestern Univeristy
Evanston, Illinois, United States, 60208
United States, Indiana
University of Indiana
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Vadim Backman, PhD Northwestern University
Principal Investigator: Hemant Roy, MD Boston University

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Responsible Party: Hemant Kumar Roy, BMC Attending Physician, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01999478     History of Changes
Other Study ID Numbers: R01CA128641 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases