Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

NCT ID: NCT00833170

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-01-28
• Study Completion Date: 2014-06-01

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.

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.

Conditions

Inflammatory Bowel Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Hyams, MD

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey S. Hyams, M.D.

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

University of Alabama

Birmingham, Alabama, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Childrens Hospital

Washington D.C., District of Columbia, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

Emory University

Atlanta, Georgia, United States

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, United States

The John's Hopkins Medical Institute

Baltimore, Maryland, United States

Children's Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Steven & Alexandra Cohen Children's Medical Center

New Hyde Park, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Children's Hospital At Montefiore

The Bronx, New York, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Dayton Children's Medical Center

Dayton, Ohio, United States

Hershey Medical Center

Hershey, Pennsylvania, United States

The Children's Hospital

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, 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

Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

PIBDCRG1

Identifier Type: -

Identifier Source: org_study_id