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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Subra Kugathasan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00790543
First received: November 12, 2008
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

At time of enrollment, whole blood for DNA and serum will be collected in all patients. Fresh fecal samples will also be requested. For gene expression analysis, biopsy specimens will be collected during regularly scheduled endoscopies.


Estimated Enrollment: 2000
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Children newly diagnosed with Crohn's disease.

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study population will consist of children newly diagnosed with Crohn's disease at primary care clinics.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790543

  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
UCLA Medical Center
Los Angeles, California, United States, 90095
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32256
United States, Georgia
Emory-Children's Center - Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States, 30342
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Riley Children's Hospital - Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hospital Boston - Harvard Medical School
Boston, Massachusetts, United States, 02115
United States, New Jersey
Goryeb Children's Hospital - Atlantic Health System
Morristown, New Jersey, United States, 07962
United States, New York
The Research Foundation of SUNY on behalf of the University at Buffalo
Buffalo, New York, United States, 14222
Cohens (Schneider) Children's Hospital
New Hyde Park, New York, United States, 11040
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
BCM Texas Children's Hospital - Houston
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Medical Center - University of Utah
Salt Lake City, Utah, United States, 84113
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K6R8
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children - Sickkids
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
Emory University
Crohn's and Colitis Foundation
Investigators
Principal Investigator: Subra Kugathasan, MD Emory University
  More Information

No publications provided

Responsible Party: Subra Kugathasan, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00790543     History of Changes
Other Study ID Numbers: IRB00012206
Study First Received: November 12, 2008
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Crohn's Disease
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Disease Progression
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014