Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT01028235
Status:
UNKNOWN
Last Update Posted:
2009-12-09
First Post:
2009-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D004941', 'term': 'Esophagitis'}, {'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_WITHOUT_DNA', 'description': '4 endoscopic biopsies from 5 locations: duodenum, stomach, distal esophagus, mid esophagus and proximal esophagus'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-08', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eosinophilic Esophagitis'], 'conditions': ['Dysphagia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the investigators will make recommendations regarding routine screening for the diagnosis in this cohort. The prevalence of EoE in patients presenting for specialty care in the gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis should be routinely screened against in this cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients over age 18, presenting to the Gastroenterology Clinic with the complaint of dysphagia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18\n* complaint of dysphagia\n\nExclusion Criteria:\n\n* pregnancy\n* age \\<18\n* on inhaled steroids within the last 30 days\n* on systemic steroids in the last 30 days\n* known diagnosis of Eosinophilic Esophagitis\n* obvious obstructive etiology found at endoscopy\n* increased risk of bleeding (on blood thinners or anti-platelet agents other than aspirin)'}, 'identificationModule': {'nctId': 'NCT01028235', 'briefTitle': 'Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia', 'organization': {'class': 'FED', 'fullName': 'San Antonio Uniformed Services Health Education Consortium'}, 'officialTitle': 'Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia', 'orgStudyIdInfo': {'id': 'FWH20060112H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obstructive Dysphagia', 'description': 'Patients who complained of dysphagia, which had an obstructive etiology for their symptoms at the time of endoscopy (ring, mass, stricture, etc)'}, {'label': 'Non-obstructive Dysphagia', 'description': 'Patients whose endoscopy was normal and without any obvious etiology for their symptoms noted.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78236', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan M Ricker, DO', 'role': 'CONTACT', 'email': 'jonathan.ricker@lackland.af.mil', 'phone': '210-292-6408'}, {'name': 'Kevin J Franklin, MD', 'role': 'CONTACT', 'email': 'kevin.franklin1@lackland.af.mil', 'phone': '210-292-6408'}, {'name': 'Jonathan M Ricker, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wilford Hall Medical Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78245', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott McNear, DO', 'role': 'CONTACT', 'email': 'scott.mcnear@amedd.army.mil', 'phone': '210-916-5244'}, {'name': 'Hays Arnold, MD', 'role': 'CONTACT', 'email': 'hays.arnold@amedd.army.mil', 'phone': '210-916-5244'}, {'name': 'Scott McNear, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Jonathan M Ricker, DO', 'role': 'CONTACT', 'email': 'jonathan.ricker@lackland.af.mil', 'phone': '210-292-6408'}, {'name': 'Scott McNeaer, DO', 'role': 'CONTACT', 'email': 'scott.mcnear@amedd.army.mil', 'phone': '210-916-5244'}], 'overallOfficials': [{'name': 'Jonathan M Ricker, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Antonio Uniformed Services Health Education Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Antonio Uniformed Services Health Education Consortium', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Jonathan M. Ricker, DO Gastroenterology Fellow', 'oldOrganization': 'SAUSHEC'}}}}