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Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Sponsor
Connecticut Children's Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00833170
Collaborator
Centocor, Inc. (Industry)
1,600
Enrollment
28
Locations
148.1
Actual Duration (Months)
57.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry is to study the contemporary natural history of children <16 years of age newly diagnosed with inflammatory bowel disease. The project follows these children quarterly from diagnosis examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is performed on the study population.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
    Actual Study Start Date :
    Jan 28, 2002
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Clinical activity following biologic and immunomodulatory therapy [10 years]

      Clinical Outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis

    2. Age up to 16 years and zero days at time of diagnosis

    3. Informed consent/assent from parent/guardian and patient

    4. Ability to be available for regular follow-up visits

    Exclusion Criteria:

    1. Diagnosis of IBD greater than 1 month prior to presentation to participating center

    2. Age greater than 16 years and zero days

    3. Inability to be available for regular follow-up visits

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Alabama United States 35233
    2 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    3 Childrens Hospital Washington District of Columbia United States 20010
    4 Nemours Children's Clinic Jacksonville Florida United States 32207-8426
    5 Emory University Atlanta Georgia United States 30322
    6 James Whitcomb Riley Hospital for Children Indianapolis Indiana United States 46202-5225
    7 The John's Hopkins Medical Institute Baltimore Maryland United States 21287-2631
    8 Children's Hospital Boston Massachusetts United States 02115
    9 University of Minnesota Minneapolis Minnesota United States 55455
    10 Mayo Clinic Rochester Minnesota United States 55905
    11 Morristown Memorial Hospital Morristown New Jersey United States 07962
    12 Children's Hospital At Montefiore Bronx New York United States 10467
    13 Steven & Alexandra Cohen Children's Medical Center New Hyde Park New York United States 11040
    14 Stony Brook University Hospital Stony Brook New York United States 11794-8111
    15 UNC Chapel Hill Chapel Hill North Carolina United States 27599
    16 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    17 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    18 Nationwide Children's Hospital Columbus Ohio United States 43205
    19 Dayton Children's Medical Center Dayton Ohio United States 45404-1898
    20 Hershey Medical Center Hershey Pennsylvania United States 17033
    21 The Children's Hospital Philadelphia Pennsylvania United States 19104
    22 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    23 Rhode Island Hospital Providence Rhode Island United States 02903
    24 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    25 IWK Health Centre, Halifax Nova Scotia Canada B3K 6R8
    26 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    27 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    28 CHU Sainte-Justine Hospital Montreal Quebec Canada H3T IC5

    Sponsors and Collaborators

    • Connecticut Children's Medical Center
    • Centocor, Inc.

    Investigators

    • Principal Investigator: Jeffrey S. Hyams, M.D., Connecticut Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeffrey Hyams, MD, Study Principal Investigator, Connecticut Children's Medical Center
    ClinicalTrials.gov Identifier:
    NCT00833170
    Other Study ID Numbers:
    • PIBDCRG1
    First Posted:
    Jan 30, 2009
    Last Update Posted:
    Feb 18, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Jeffrey Hyams, MD, Study Principal Investigator, Connecticut Children's Medical Center
    pediatric inflammatory bowel disease
    multiple site study
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Feb 18, 2019