Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

February 15, 2019 updated by: Jeffrey Hyams, MD, Connecticut Children's Medical Center
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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre,
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital For Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T IC5
        • CHU Sainte-Justine Hospital
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Childrens Hospital
    • Florida
      • Jacksonville, Florida, United States, 32207-8426
        • Nemours Children's Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5225
        • James Whitcomb Riley Hospital for Children
    • Maryland
      • Baltimore, Maryland, United States, 21287-2631
        • The John's Hopkins Medical Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University Of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Children's Hospital at Montefiore
      • New Hyde Park, New York, United States, 11040
        • Steven & Alexandra Cohen Children's Medical Center
      • Stony Brook, New York, United States, 11794-8111
        • Stony Brook University Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
      • Dayton, Ohio, United States, 45404-1898
        • Dayton Children's Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children <16 years old with inflammatory bowel disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Clinical Outcomes
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2002

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

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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