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

Completed

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00790543

Run by

Emory University

People needed

1813

Starts

2008-11-01

Expected to finish

2020-12-31

Last updated by the study team

2021-11-16

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Infectious colitis.
• Final eligibility will be determined by the health professionals conducting this clinical trial.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, 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
• Emory-Children's Center - Emory University School of Medicine — Atlanta, Georgia, United States
• Children's Center for Digestive Healthcare — Atlanta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• Riley Children's Hospital - Indiana University School of Medicine — Indianapolis, Indiana, United States
• Johns Hopkins Children's Center — Baltimore, Maryland, United States
• Children's Hospital Boston - Harvard Medical School — Boston, Massachusetts, 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
• 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
• Rhode Island Hospital — Providence, Rhode Island, United States
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
• Children's Medical Center — Dallas, Texas, United States
• BCM Texas Children's Hospital - Houston — Houston, Texas, United States
• Primary Children's Medical Center - University of Utah — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.