Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
- Conditions
- Inflammatory Bowel Disease
- Registration Number
- NCT00833170
- Lead Sponsor
- Connecticut Children's Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
- Definite diagnosis of ulcerative colitis, Crohn's disease, indeterminate colitis
- Age up to 16 years and zero days at time of diagnosis
- Informed consent/assent from parent/guardian and patient
- Ability to be available for regular follow-up visits
- Diagnosis of IBD greater than 1 month prior to presentation to participating center
- Age greater than 16 years and zero days
- Inability to be available for regular follow-up visits
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical activity following biologic and immunomodulatory therapy 10 years Clinical Outcomes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
The John's Hopkins Medical Institute
🇺🇸Baltimore, Maryland, United States
The Children's Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
James Whitcomb Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Children's Hospital At Montefiore
🇺🇸Bronx, New York, United States
Steven & Alexandra Cohen Children's Medical Center
🇺🇸New Hyde Park, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Childrens Hospital
🇺🇸Washington, District of Columbia, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
IWK Health Centre,
🇨🇦Halifax, Nova Scotia, Canada
CHU Sainte-Justine Hospital
🇨🇦Montreal, Quebec, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Dayton Children's Medical Center
🇺🇸Dayton, Ohio, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States