Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

July 30, 2018 updated by: American BioOptics, LLC
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be obtained in the gastroenterology clinics.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American BioOptics, LLC

Investigators

  • Principal Investigator: The Quyen Nguyen, Ph.D., American BioOptics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABO 2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will assure the confidentiality of all human subjects' data and will adhere to all HIPAA rules by, for example, de-identifying data as appropriate to ensure compliance with human subject confidentiality requirements. The investigators will share research outcomes through conference presentations, and through publications as soon as is feasible after peer review.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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