Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease (RS)
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|ClinicalTrials.gov Identifier: NCT00790543|
Recruitment Status : Active, not recruiting
First Posted : November 13, 2008
Last Update Posted : July 23, 2020
|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|
|Actual Enrollment :||1813 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 2020|
|Estimated Study Completion Date :||December 2020|
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
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): NCT00790543
|Principal Investigator:||Subra Kugathasan, MD||Emory University|