- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00833170
Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
Study Overview
Status
Conditions
Detailed Description
Observations of children with IBD often suggest a more severe course than that found in adults. Explanations for this are unclear, especially since children are less likely to engage in some behaviors (e.g., smoking) that may have a deleterious effect on disease course as noted in adults. In many ways children are a better "experimental model" of IBD because they don't have as many confounding medical factors as adults. Both Crohn's disease and ulcerative colitis are believed to result from a complex interaction of genetic and environmental factors (1). Recently, the gene CARD15/NOD2 on chromosome 16 has been identified in approximately 25% of Caucasian patients with Crohn's disease and is felt to be a significant predisposing factor to the development of fibrostenosing disease (2). Additionally, seropositivity for perinuclear antinuclear cytoplasmic factor (pANCA) has been demonstrated much more frequently in patients with ulcerative colitis than in those with Crohn's disease, while anti-Saccharomyces antibody (ASCA) is more common in the latter population (3). The importance of these serological abnormalities is not clear, though some data suggest an influence on the development of complications.
Our hypothesis is that phenotypic, genotypic and serologic characteristics may provide prognostic information on response to therapy and course in children with IBD. This type of prognostic information is particularly important as newer therapies are developed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre,
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital For Sick Children
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Quebec
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Montreal, Quebec, Canada, H3T IC5
- CHU Sainte-Justine Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Childrens Hospital
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Florida
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Jacksonville, Florida, United States, 32207-8426
- Nemours Children's Clinic
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Indiana
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Indianapolis, Indiana, United States, 46202-5225
- James Whitcomb Riley Hospital for Children
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Maryland
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Baltimore, Maryland, United States, 21287-2631
- The John's Hopkins Medical Institute
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University Of Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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New Jersey
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Morristown, New Jersey, United States, 07962
- Morristown Memorial Hospital
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New York
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Bronx, New York, United States, 10467
- Children's Hospital at Montefiore
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New Hyde Park, New York, United States, 11040
- Steven & Alexandra Cohen Children's Medical Center
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Stony Brook, New York, United States, 11794-8111
- Stony Brook University Hospital
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Chapel Hill
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, United States, 44195
- The Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, United States, 45404-1898
- Dayton Children's Medical Center
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis
- Age up to 16 years and zero days at time of diagnosis
- Informed consent/assent from parent/guardian and patient
- Ability to be available for regular follow-up visits
Exclusion Criteria:
- Diagnosis of IBD greater than 1 month prior to presentation to participating center
- Age greater than 16 years and zero days
- Inability to be available for regular follow-up visits
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical activity following biologic and immunomodulatory therapy
Time Frame: 10 years
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Clinical Outcomes
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10 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeffrey S. Hyams, M.D., Connecticut Children's Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIBDCRG1
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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-
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