Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Jeffrey Hyams, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00833170
First received: January 28, 2009
Last updated: February 3, 2015
Last verified: February 2015
  Purpose

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
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Clinical activity following biologic and immunomodulatory therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 1000
Study Start Date: January 2002
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children <16 years old with inflammatory bowel disease

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833170

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

No publications provided

Responsible Party: Jeffrey Hyams, MD, Study Principal Investigator, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00833170     History of Changes
Other Study ID Numbers: PIBDCRG1
Study First Received: January 28, 2009
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
pediatric inflammatory bowel disease
multiple site study

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on June 28, 2015