View Clinical Trial (Medical Research Study)
Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children With Crohn's Disease
| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46202 |
| Conditions: |
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Crohn's Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00790543 |
| Primary Contact: |
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Principal Investigator
Subra Kugathasan, MD
Emory University
Subra Kugathasan, MD
Phone: 404-727-4542
Email: skugath@emory.edu
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| Backup Contact: |
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Email: cathy.brashear@emory.edu
Cathy Brashear, MSN
Phone: 404-727-1190
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| Location Contact: |
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Indianapolis, Indiana 46202
United States
Trisha Davis, RN
Phone: 317-278-5858
Email: tawilson@iupui.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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