Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-01 @ 2:47 PM
Study NCT ID:
NCT02200250
Status:
WITHDRAWN
Last Update Posted:
2023-07-03
First Post:
2014-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Barrett's Endoscopic Mucosal Resection Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study abandoned', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2014-07-17', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reviewing patients symptoms following resection', 'timeFrame': 'up to 3 years', 'description': 'Patients will be contacted via phone and will be required to answer questions over the phone. Health questionnaires may also be sent at the patients request to complete and post back.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Barretts Esophagus']}, 'descriptionModule': {'briefSummary': "Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients who have or have had Barrett's Oesophagus with high grade dysplasia or adenocarcinoma.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or over\n* Have or have had Barrett's Oesophagus\n\nExclusion Criteria:\n\n* Do not have Barrett's Oesophagus\n* Have not had Barrett's Oesophagus resected at Westmead Hospital"}, 'identificationModule': {'nctId': 'NCT02200250', 'acronym': 'CBE', 'briefTitle': "Long Term Barrett's Endoscopic Mucosal Resection Study", 'organization': {'class': 'OTHER', 'fullName': 'Western Sydney Local Health District'}, 'officialTitle': "Long Term Outcomes of Patients Undergoing Endoscopic Resection of Barrett's Oesophagus (BO) With High Grade Dysplasia (HGD) and Early Adenocarcinoma", 'orgStudyIdInfo': {'id': 'HREC2013/10/6.2(3838)QA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post Barretts Excision', 'description': 'Patients who have undergone an EMR for Barretts Oesophagus'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Endoscopy Unit', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}], 'overallOfficials': [{'name': 'Michael J Bourke, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Sydney Local Health District'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Professor Michael Bourke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Gastrointestinal Endoscopy', 'investigatorFullName': 'Professor Michael Bourke', 'investigatorAffiliation': 'Western Sydney Local Health District'}}}}