Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01281618
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
2011-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005773', 'term': 'Gastroscopy'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Tissue specimens from Barrett's esophagus"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-03', 'studyFirstSubmitDate': '2011-01-20', 'studyFirstSubmitQcDate': '2011-01-20', 'lastUpdatePostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'activated myofibroblasts', 'timeFrame': '6 months', 'description': 'The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in \\> 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Barrett's esophagus"], 'conditions': ["Barrett's Esophagus"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.\n\nSpecific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.\n\nSpecific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low grade dysplasia", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment \\>/= 1 cm\n2. Absence of dysplasia or LGD on biopsies within the past 5 years\n3. Ability to provide informed consent\n4. Age between 18 years and 90 years at study entry.\n\nExclusion criteria:\n\n1. Eastern Cooperative Oncology Group performance status 3 or 4\n2. Inability to tolerate endoscopic procedures\n3. Pregnancy: Females of child-bearing age will be screened with pregnancy test.\n4. Prior esophageal surgery, or cancer"}, 'identificationModule': {'nctId': 'NCT01281618', 'acronym': 'CR20', 'briefTitle': "Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus", 'orgStudyIdInfo': {'id': '07-004899'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Those with barrett's esophagus", 'description': "Those with barrett's esophagus: no dysplasia or low grade dysplasia", 'interventionNames': ['Procedure: 24 hour pH study and upper endoscopy (EGD)']}], 'interventions': [{'name': '24 hour pH study and upper endoscopy (EGD)', 'type': 'PROCEDURE', 'description': 'All subjects enrolled will undergo 24 hour pH followed by EGD.', 'armGroupLabels': ["Those with barrett's esophagus"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Prasad G. Iyer', 'investigatorAffiliation': 'Mayo Clinic'}}}}