Eosinophilic Esophagitis Databank

Eosinophilic Esophagitis Clinical Trial

— CoFAR5  

Official title:

Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323803
• Other study ID #: DAIT CoFAR5
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: August 24, 2017
• Start date: April 2011
• Est. completion date: February 2016

Study information

• Verified date: August 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of North Carolina	Chapel Hill	North Carolina
United States	National Jewish Health	Denver	Colorado
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, Mukkad — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis	A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from >1.5 million genetic markers will be conducted.	48 months

External Links

•   Consortium of Food Allergy Research (CoFAR)
•   National Institute of Allergy and Infectious Diseases (NIAID)
•   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)