Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 16
Updated:1/19/2019
Start Date:November 2008
End Date:December 2019

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Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease

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.

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.

Inclusion Criteria:

- 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 Criteria:

- Infectious colitis.

- Final eligibility will be determined by the health professionals conducting this
clinical trial.
We found this trial at
26
sites
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Atlanta, GA
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Baltimore, Maryland 21287
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Dallas, Texas 75235
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Halifax, Nova Scotia
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Indianapolis, IN
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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New Hyde Park, New York 11040
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San Francisco, California 94143
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