Eosinophilic Esophagitis Databank
This trial has been completed.
|Conditions||esophagitis, eosinophilic esophagitis|
|Sponsor||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborator||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Start date||April 2011|
|End date||February 2016|
|Trial size||709 participants|
|Trial identifier||NCT01323803, DAIT CoFAR5|
This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Little Rock, AR||Arkansas Children's Hospital||completed|
|Denver, CO||National Jewish Health||completed|
|Baltimore, MD||Johns Hopkins University||completed|
|New York, NY||Mount Sinai School of Medicine||completed|
|Chapel Hill, NC||University of North Carolina||completed|
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis
time frame: 48 months
Male or female participants from 6 months up to 65 years old.
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 a history of persistent eosinophilia greater than 1500 cells/mcl of blood.
|Official title||Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)|
|Principal investigator||Marc E. Rothenberg, M.D., Ph.D.|
|Description||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. 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.|
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