Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease
NCT ID: NCT00790543
Last Updated: 2021-11-16
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
1813 participants
OBSERVATIONAL
2008-11-30
2020-12-31
Brief Summary
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Detailed Description
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A total of 2000 children with newly-diagnosed Crohn's disease will be enrolled within 30 days of diagnosis. Up to 28 medical sites in the United States and Canada will participate in the study.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation
Children newly diagnosed with Crohn's disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent or the ability to obtain written informed consent from the parents or patient's legal guardian in conjunction with youth assent.
* Consented to have specimens tested for genetics and immune responses.
* Access to follow-up data for a minimum of 36 months after diagnosis.
* Final eligibility will be determined by the health professionals conducting this clinical trial.
Exclusion Criteria
* Final eligibility will be determined by the health professionals conducting this clinical trial.
5 Days
16 Years
ALL
No
Sponsors
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Crohn's and Colitis Foundation
OTHER
Emory University
OTHER
Responsible Party
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Subra Kugathasan, MD
Professor
Principal Investigators
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Subra Kugathasan, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Emory-Children's Center - Emory University School of Medicine
Atlanta, Georgia, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Riley Children's Hospital - Indiana University School of Medicine
Indianapolis, Indiana, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Children's Hospital Boston - Harvard Medical School
Boston, Massachusetts, United States
Goryeb Children's Hospital - Atlantic Health System
Morristown, New Jersey, United States
The Research Foundation of SUNY on behalf of the University at Buffalo
Buffalo, New York, United States
Cohens (Schneider) Children's Hospital
New Hyde Park, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Center
Dallas, Texas, United States
BCM Texas Children's Hospital - Houston
Houston, Texas, United States
Primary Children's Medical Center - University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
IWK Health Centre
Halifax, Nova Scotia, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children - Sickkids
Toronto, Ontario, Canada
Countries
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References
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Ballengee CR, Stidham RW, Liu C, Kim MO, Prince J, Mondal K, Baldassano R, Dubinsky M, Markowitz J, Leleiko N, Hyams J, Denson L, Kugathasan S. Association Between Plasma Level of Collagen Type III Alpha 1 Chain and Development of Strictures in Pediatric Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1799-1806. doi: 10.1016/j.cgh.2018.09.008. Epub 2018 Sep 10.
Other Identifiers
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IRB00012206
Identifier Type: -
Identifier Source: org_study_id