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Eosinophilic Esophagitis Databank (CoFAR5)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323803
First Posted: March 28, 2011
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
March 24, 2011
March 28, 2011
August 28, 2017
April 2011
February 2016   (Final data collection date for primary outcome measure)
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis [ Time Frame: 48 months ]
A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from >1.5 million genetic markers will be conducted.
Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis [ Time Frame: 48 months ]
Complete list of historical versions of study NCT01323803 on ClinicalTrials.gov Archive Site
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Eosinophilic Esophagitis Databank
Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)
This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:
blood and saliva
Probability Sample
Participants with biopsy proven Eosinophilic Esophagitis
  • Esophagitis
  • Eosinophilic Esophagitis
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Kottyan LC, Davis BP, Sherrill JD, Liu K, Rochman M, Kaufman K, Weirauch MT, Vaughn S, Lazaro S, Rupert AM, Kohram M, Stucke EM, Kemme KA, Magnusen A, He H, Dexheimer P, Chehade M, Wood RA, Pesek RD, Vickery BP, Fleischer DM, Lindbad R, Sampson HA, Mukkada VA, Putnam PE, Abonia JP, Martin LJ, Harley JB, Rothenberg ME. Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet. 2014 Aug;46(8):895-900. doi: 10.1038/ng.3033. Epub 2014 Jul 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
709
February 2016
February 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Months to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01323803
DAIT CoFAR5
Yes
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
National Institute of Allergy and Infectious Diseases (NIAID)
August 2017