Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
NCT ID: NCT02503696
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
697 participants
OBSERVATIONAL
2014-09-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Stool Collection Kit
Stool Collection Kit.
Interventions
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Stool Collection Kit
Stool Collection Kit.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
84 Years
ALL
No
Sponsors
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Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Graham Lidgard, PhD
Role: STUDY_CHAIR
Exact Sciences
Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
UC San Diego Medical Center
La Jolla, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Medical Research Center of Conneticut
Hamden, Connecticut, United States
Edward Hines Jr. VA Hospital
Hines, Illinois, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Delta Research Partners
Monroe, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
HealthEast Midway Clinic
Saint Paul, Minnesota, United States
Gastrointestinal Associates
Jackson, Mississippi, United States
AGA Clinical Research Associates, LLC
Egg Harbor TWP, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Kinston Medical Specialists, PA
Kinston, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
UC Health
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
University of Calgary - Division of Gastroenterology
Calgary, Alberta, Canada
Winnipeg Regional Health Authority- Health Sciences
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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2014-05
Identifier Type: -
Identifier Source: org_study_id
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