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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
History of Changes
  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

  Show 28 Study Locations
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 March 02, 2015