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

Crohn's Disease Clinical Trial

— RS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790543
• Other study ID #: IRB00012206
• Status: Completed
• Start date: November 2008
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1813
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Disease Progression

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital for Sick Children - Sickkids	Toronto	Ontario
United States	Children's Center for Digestive Healthcare	Atlanta	Georgia
United States	Emory-Children's Center - Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins Children's Center	Baltimore	Maryland
United States	Children's Hospital Boston - Harvard Medical School	Boston	Massachusetts
United States	The Research Foundation of SUNY on behalf of the University at Buffalo	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	The University of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Medical Center	Dallas	Texas
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	BCM Texas Children's Hospital - Houston	Houston	Texas
United States	Riley Children's Hospital - Indiana University School of Medicine	Indianapolis	Indiana
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Goryeb Children's Hospital - Atlantic Health System	Morristown	New Jersey
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Cohens (Schneider) Children's Hospital	New Hyde Park	New York
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	Primary Children's Medical Center - University of Utah	Salt Lake City	Utah
United States	University of California at San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Crohn's and Colitis Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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