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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02503696
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : August 10, 2016
Information provided by (Responsible Party):
Exact Sciences Corporation

Brief Summary:
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).

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer Device: Stool Collection Kit

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Study Type : Observational
Actual Enrollment : 697 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : June 2016

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
Provide anonymous, clinically characterized specimens for bio-repository for future colorectal cancer-related test development.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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 identifier (NCT number): NCT02503696

Hide Hide 29 study locations
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United States, Alabama
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
United States, California
UC San Diego Medical Center
La Jolla, California, United States, 92093
Facey Medical Foundation
Mission Hills, California, United States, 91345
United States, Connecticut
Medical Research Center of Conneticut
Hamden, Connecticut, United States, 06518
United States, Illinois
Edward Hines Jr. VA Hospital
Hines, Illinois, United States, 60141
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
Delta Research Partners
Monroe, Louisiana, United States, 71201
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71103
United States, Maryland
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
HealthEast Midway Clinic
St. Paul, Minnesota, United States, 55104
United States, Mississippi
Gastrointestinal Associates
Jackson, Mississippi, United States, 39202
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbor TWP, New Jersey, United States, 08234
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Kinston Medical Specialists, PA
Kinston, North Carolina, United States, 28501
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
UC Health
Cincinnati, Ohio, United States, 45267
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Virginia
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 24502
United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53705
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
University of Calgary - Division of Gastroenterology
Calgary, Alberta, Canada, T2N1N4
Canada, Manitoba
Winnipeg Regional Health Authority- Health Sciences
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
Exact Sciences Corporation
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Study Chair: Graham Lidgard, PhD Exact Sciences

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Responsible Party: Exact Sciences Corporation Identifier: NCT02503696    
Other Study ID Numbers: 2014-05
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Exact Sciences Corporation:
Inflammatory Bowel Disease
Colorectal Cancer
Colorectal Neoplasm
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Colonic Diseases
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases