Risk Stratification of Rapid Disease Progression in Children With Crohn's Disease (RS)
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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 |
- 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 ]
- 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 |
|---|
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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 will consist of children newly diagnosed with Crohn's disease at primary care clinics.
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| Contact: Subra Kugathasan, MD | 404-727-4542 | skugath@emory.edu |
| Contact: Cathy Brashear, MSN | 404-727-1190 | cathy.brashear@emory.edu |
Show 28 Study Locations| 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: | 12206 |
| Study First Received: | November 12, 2008 |
| Last Updated: | May 30, 2012 |
| 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 May 22, 2013