Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00833170|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2009
Last Update Posted : January 26, 2018
|Condition or disease|
|Inflammatory Bowel Disease|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- Clinical activity following biologic and immunomodulatory therapy [ Time Frame: 10 years ]Clinical Outcomes
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833170
Show 28 Study Locations
|Principal Investigator:||Jeffrey S. Hyams, M.D.||Connecticut Children's Medical Center|