Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease (RS)
|ClinicalTrials.gov Identifier: NCT00790543|
Recruitment Status : Active, not recruiting
First Posted : November 13, 2008
Last Update Posted : January 9, 2018
|Condition or disease|
It is estimated that between 15-20% of children with Crohn's disease will develop complications that can require surgery within the first three years of diagnosis. The purpose of this study for children with a new diagnosis of Crohn's disease is to identify biomarkers found in the blood or stool to help predict which children are at risk of developing complications.
A total of 2000 children with newly-diagnosed Crohn's disease will be enrolled within 30 days of diagnosis. Up to 28 medical sites in the United States and Canada will participate in the study.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Children newly diagnosed with Crohn's disease.
- Identify demographic, clinical, microbial, genetic, and/or immunologic risk factors influencing the likelihood of rapid development of complicated disease phenotypes manifested as penetrating or stricturing disease and need for surgery. [ Time Frame: 3 years ]
- Develop and validate risk stratification by stratifying patients into different levels of risk at diagnosis based on clinical, demographic, host microbial ecology, immune, and genetic determinants. [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790543
Show 28 Study Locations
|Principal Investigator:||Subra Kugathasan, MD||Emory University|