Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease - Full Text View

Sponsors and Collaborators:	Emory University Crohn's and Colitis Foundation
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00790543

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:	Cohort, 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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

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

Biospecimen Description:

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

Estimated Enrollment:	1000
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (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 1000 children will be enrolled within 30 days of diagnosis. Over 50 medical facilities in the United States 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 16 years of age (before their 16th birthday). An upper limit of 16 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

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

Contacts

Contact: Subra Kugathasan, MD	404-727-4542	skugath@emory.edu
Contact: Teresa Stilley, MBA	404-727-1190	tstille@emory.edu

Locations

United States, California
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Sharmayne Farrior, RN 310-423-1686 sharmayne.farrior@cshs.org
Sub-Investigator: Marla Dubinsky, MD
United States, Connecticut
Connecticut Children's Medical Center	Recruiting
Hartford, Connecticut, United States, 06106
Contact: Miriam Lincoln 860-545-9540 mlincoln@ccmckids.org
Sub-Investigator: Jeffrey Hyams, MD
United States, Georgia
Emory University Children's Center	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Teresa Stilley 404-727-4542 tstille@emory.edu
Contact: Laketia Woodley 404-727-4542 twoodle@emory.edu
Principal Investigator: Subra Kugathasan, MD
United States, New York
Schneider Children's Hospital	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Kathy Grancher 718-470-3363 kgranche@nshs.edu
Sub-Investigator: James Markowitz, MD
United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kathleen Lake 513-636-0572 kathleen.lake@cchmc.org
Sub-Investigator: Ted Denson, MD
United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kelly Cochlin, RN 215-590-0971 cochlinke@email.chop.edu
Sub-Investigator: Robert Baldassano, MD
United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Kristin Ciezki, MS 414-266-4844 kciezki@mcw.edu
Sub-Investigator: Michael Stephens, MD

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:	Emory University ( Subra Kugathasan, MD )
Study ID Numbers:	12206
Study First Received:	November 12, 2008
Last Updated:	August 22, 2009
ClinicalTrials.gov Identifier:	NCT00790543 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Crohn's Disease
Inflammatory Bowel Disease
Ulcerative Colitis

Study placed in the following topic categories:

Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Ulcer
Disease Progression
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Ileal Diseases
Digestive System Diseases
Crohn Disease
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis

Crohn Disease
Disease Progression
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Ileal Diseases

ClinicalTrials.gov processed this record on September 10, 2009