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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

  Show 28 Study Locations
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
Digestive System Diseases
Disease Attributes
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014