Status:
COMPLETED
Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
Crohn's and Colitis Foundation
Conditions:
Crohn's Disease
Eligibility:
All Genders
5-16 years
Brief Summary
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 complicati...
Detailed Description
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 childr...
Eligibility Criteria
Inclusion
- Males and females younger than 17 years of age (before their 17th birthday). An upper limit of 17 years of age was selected as important inclusion criteria to maximize the number of potential subjects that would be diagnosed and followed by a pediatric gastroenterologist for at least 3 years.
- Confirmed or suspected diagnosis of Crohn's disease based on standardized diagnostic criteria. The enrollment should occur within 30 days of diagnosis.
- Able to provide written informed consent or the ability to obtain written informed consent from the parents or patient's legal guardian in conjunction with youth assent.
- Consented to have specimens tested for genetics and immune responses.
- Access to follow-up data for a minimum of 36 months after diagnosis.
- Final eligibility will be determined by the health professionals conducting this clinical trial.
Exclusion
- Infectious colitis.
- Final eligibility will be determined by the health professionals conducting this clinical trial.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
1813 Patients enrolled
Trial Details
Trial ID
NCT00790543
Start Date
November 1 2008
End Date
December 31 2020
Last Update
November 16 2021
Active Locations (28)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
UCLA Medical Center
Los Angeles, California, United States, 90095
3
University of California at San Francisco
San Francisco, California, United States, 94143
4
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106