Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)

August 9, 2016 updated by: Exact Sciences Corporation
The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

697

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N1N4
        • University of Calgary - Division of Gastroenterology
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Winnipeg Regional Health Authority- Health Sciences
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Medical Center
      • Mission Hills, California, United States, 91345
        • FACEY Medical Foundation
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Conneticut
    • Illinois
      • Hines, Illinois, United States, 60141
        • Edward Hines Jr. VA Hospital
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, LLC
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
      • Shreveport, Louisiana, United States, 71103
        • Louisiana Research Center, LLC
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • St. Paul, Minnesota, United States, 55104
        • HealthEast Midway Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Gastrointestinal Associates
    • New Jersey
      • Egg Harbor TWP, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, PA
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Kinston, North Carolina, United States, 28501
        • Kinston Medical Specialists, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • UC Health
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center, LLC
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Hospital & Clinics
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research

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

18 years to 84 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are at risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.

Description

Inclusion Criteria:

  • Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD.
  • Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia.
  • Written informed consent document signed and dated by the subject.

Exclusion Criteria:

  • Any condition that in the opinion of the investigator should preclude participation in the study.
  • A history of aerodigestive tract cancer.
  • Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
  • IBD limited only to the rectum.
  • Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IBD
Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings.
Device: Stool Collection Kit
Stool Collection Kit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of the Exact CRC diagnostic screening test.
Time Frame: 15 months
The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.
15 months

Collaborators and Investigators

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

Sponsor

Exact Sciences Corporation

Investigators

  • Study Chair: Graham Lidgard, PhD, Exact Sciences

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, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 21, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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