Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00790543
- Lead Sponsor
- Emory University
- 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 complications.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1813
- 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.
- Infectious colitis.
- Final eligibility will be determined by the health professionals conducting this clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 3 years
- Secondary Outcome Measures
Name Time Method 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. 3 years
Trial Locations
- Locations (28)
Children's Center for Digestive Healthcare
🇺🇸Atlanta, Georgia, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins Children's Center
🇺🇸Baltimore, Maryland, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Medical Center
🇺🇸Dallas, Texas, United States
Children's Hospital Boston - Harvard Medical School
🇺🇸Boston, Massachusetts, United States
Primary Children's Medical Center - University of Utah
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
The Hospital for Sick Children - Sickkids
🇨🇦Toronto, Ontario, Canada
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Emory-Children's Center - Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Riley Children's Hospital - Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Goryeb Children's Hospital - Atlantic Health System
🇺🇸Morristown, New Jersey, United States
The Research Foundation of SUNY on behalf of the University at Buffalo
🇺🇸Buffalo, New York, United States
Cohens (Schneider) Children's Hospital
🇺🇸New Hyde Park, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
BCM Texas Children's Hospital - Houston
🇺🇸Houston, Texas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States