Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Inflammatory Bowel Disease

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 Design

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Study Type :	Observational
Estimated Enrollment :	1000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
Actual Study Start Date :	January 28, 2002
Estimated Primary Completion Date :	August 2019
Estimated Study Completion Date :	August 2019

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Clinical activity following biologic and immunomodulatory therapy [ Time Frame: 10 years ]
   Clinical Outcomes

Biospecimen Retention:   Samples With DNA

Blood

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	1 Month to 16 Years (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	January 30, 2009
Last Update Posted:	January 26, 2018
Last Verified:	January 2018

Keywords provided by Jeffrey Hyams, MD, Connecticut Children's Medical Center:

pediatric inflammatory bowel disease; multiple site study

Additional relevant MeSH terms:

Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis