Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-27 @ 3:17 AM
Study NCT ID:
NCT01323803
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2011-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eosinophilic Esophagitis Databank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 709}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-24', 'studyFirstSubmitDate': '2011-03-24', 'studyFirstSubmitQcDate': '2011-03-24', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elucidate the genetic components of EoE, focusing on a candidate gene approach the TSLP/WDR36 locus and through GWAS analysis', 'timeFrame': '48 months', 'description': 'A Genome-Wide Association Study (GWAS) analysis of single-nucleotide polymorphisms (SNPs) from \\>1.5 million genetic markers will be conducted.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eosinophilic Esophagitis'], 'conditions': ['Esophagitis', 'Eosinophilic Esophagitis']}, 'referencesModule': {'references': [{'pmid': '25017104', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, {'url': 'https://www.niddk.nih.gov/', 'label': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'descriptionModule': {'briefSummary': 'This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.', 'detailedDescription': "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.\n\nThe samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis.\n\nThe Cincinnati Children's Hospital Medical Center will serve as the Central Laboratory for genetic characterization studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with biopsy proven Eosinophilic Esophagitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing;\n* 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).\n\nExclusion Criteria:\n\n* Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites;\n* Participants with a history of persistent eosinophilia greater than 1500 cells/mcl of blood.'}, 'identificationModule': {'nctId': 'NCT01323803', 'acronym': 'CoFAR5', 'briefTitle': 'Eosinophilic Esophagitis Databank', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Eosinophilic Esophagitis (EoE) Databank (CoFAR 5)', 'orgStudyIdInfo': {'id': 'DAIT CoFAR5'}}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Marc E. Rothenberg, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Mirna Chehade, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mt. Sinai School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}