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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00783575
Other study ID # CHW 02/142
Secondary ID
Status Withdrawn
Phase N/A
First received October 29, 2008
Last updated August 21, 2015
Start date October 2002
Est. completion date January 2015

Study information

Verified date August 2015
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to look for the NOD2 gene in children with Inflammatory Bowel Disease (IBD) and their parents. We hope to understand this NOD2 gene better by determining whether children that have IBD have the NOD2 gene. In those with the NOD2 gene, we want to see if the type of gene abnormality predicts the nature of their disease and if the genetic information helps doctors decide what therapies and/or treatments to use for their patients. We also hope to explore the relationships between known serologic markers of IBD (ASCA, pANCA, ompC) and the clinical characteristics and course of children with IBD.

About 1500 children and as many of their parents as possible will take part in this study. Children who are newly diagnosed with IBD as well as children that are being seen in the Children's Health System are eligible to participate in this study. We are looking for children 18 years old or younger to participate. If possible, we would also like both parents of the child to participate.


Description:

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Study Design

Observational Model: Family-Based, Time Perspective: Prospective


Locations

Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Outcome

Type Measure Description Time frame Safety issue
Primary Genotype a cohort of IBD children for 4 NOD2/CARD15 mutations. Study completion No
Secondary Statistical analysis of phenotype and genotype correlation in a cohort of pediatric Inflammatory Bowel Disease children with or without a family history of Inflammatory Bowel Disease Study completion No
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