Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease
RS
Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease
1 other identifier
observational
1,813
2 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedNovember 16, 2021
November 1, 2021
12.2 years
November 12, 2008
November 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Observation
Children newly diagnosed with Crohn's disease.
Eligibility Criteria
Study population will consist of children newly diagnosed with Crohn's disease at primary care clinics.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Crohn's and Colitis Foundationcollaborator
Study Sites (28)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Nemours Children's Clinic
Jacksonville, Florida, 32256, United States
Emory-Children's Center - Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Riley Children's Hospital - Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287, United States
Children's Hospital Boston - Harvard Medical School
Boston, Massachusetts, 02115, United States
Goryeb Children's Hospital - Atlantic Health System
Morristown, New Jersey, 07962, United States
The Research Foundation of SUNY on behalf of the University at Buffalo
Buffalo, New York, 14222, United States
Cohens (Schneider) Children's Hospital
New Hyde Park, New York, 11040, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Children's Medical Center
Dallas, Texas, 75235, United States
BCM Texas Children's Hospital - Houston
Houston, Texas, 77030, United States
Primary Children's Medical Center - University of Utah
Salt Lake City, Utah, 84113, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
IWK Health Centre
Halifax, Nova Scotia, B3K6R8, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
The Hospital for Sick Children - Sickkids
Toronto, Ontario, M5G1X8, Canada
Related Publications (1)
Ballengee CR, Stidham RW, Liu C, Kim MO, Prince J, Mondal K, Baldassano R, Dubinsky M, Markowitz J, Leleiko N, Hyams J, Denson L, Kugathasan S. Association Between Plasma Level of Collagen Type III Alpha 1 Chain and Development of Strictures in Pediatric Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1799-1806. doi: 10.1016/j.cgh.2018.09.008. Epub 2018 Sep 10.
PMID: 30213581DERIVED
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Subra Kugathasan, MD
Emory University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 13, 2008
Study Start
November 1, 2008
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
November 16, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share