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Eosinophilic Esophagitis Databank
This study is currently recruiting participants.
Verified May 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01323803
First received: March 24, 2011
Last updated: May 15, 2012
Last verified: May 2012
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Purpose
Eosinophilic esophagitis (EoE) is a newly recognized chronic disease that is increasingly being diagnosed in children and adults. Many patients with EoE also have food allergies. EoE is characterized by inflammation and accumulation of a specific type of immune cell, called an eosinophil, in the esophagus. While there have been several large studies of EoE, very few have focused on the roles the immune system, genetics/heredity, and the environment in EoE. This study will establish a registry for participants with EoE and create a research resource that will provide further insights into EoE. The samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis.
The Cincinnati Children's Hospital Medical Center will serve as the central laboratory for genetic characterization studies.
| Condition |
|---|
|
Esophagitis Eosinophilic Esophagitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Eosinophilic Esophagitis (EoE) Databank (CoFAR 5) |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood and saliva
| Estimated Enrollment: | 600 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 6 Months to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Participants with biopsy proven Eosinophilic Esophagitis
Criteria
Inclusion Criteria:
- Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing
- Documented diagnosis of EoE at any time confirmed by study team (pathology report describing greater than or equal to 15 eosinophils/hpf in peak field of an esophageal biopsy. Participants with eosinophilia in extra-esophageal tissue are permitted.)
Exclusion Criteria:
- Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites.
- Participants with history of persistent eosinophilia greater than 1500 cells/mcl of blood
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323803
Locations
| United States, Arkansas | |
| Arkansas Children's Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Anne Hiegel 501-364-3755 | |
| Principal Investigator: Stacie Jones, MD | |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Jill Slinkard 303-398-1618 | |
| Principal Investigator: David Fleischer, MD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Kim Mudd 410-502-1711 | |
| Principal Investigator: Robert Wood, MD | |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Jessica Chao 212-241-7637 | |
| Principal Investigator: Mirna Chehade, MD | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Pamela Steele, MSN, CPNP, AE-C (919) 966-4647 phsteele@email.unc.edu | |
| Principal Investigator: Wesley Burks, MD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Marc E. Rothenberg, M.D., Ph.D. | Children's Hospital Medical Center, Cincinnati |
| Principal Investigator: | Mirna Chehade, MD, MPH | Mt. Sinai School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01323803 History of Changes |
| Other Study ID Numbers: | DAIT CoFAR 5 |
| Study First Received: | March 24, 2011 |
| Last Updated: | May 15, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Eosinophilic Esophagitis |
Additional relevant MeSH terms:
|
Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013