Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-01-07 @ 6:02 AM
Study NCT ID:
NCT00987857
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D057166', 'term': 'High-Throughput Screening Assays'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'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'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness'}, {'measure': 'Incidence of esophageal cancer, gastric or esophageal cancer, or all cancers'}, {'measure': 'Time to diagnosis of esophageal adenocarcinoma'}, {'measure': 'Stage of esophageal adenocarcinoma at diagnosis using TNM staging'}, {'measure': 'Morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions'}, {'measure': 'Frequency of endoscopy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['esophageal cancer', 'adenocarcinoma of the esophagus', 'Barrett esophagus'], 'conditions': ['Esophageal Cancer', 'Precancerous Condition']}, 'referencesModule': {'references': [{'pmid': '40180292', 'type': 'DERIVED', 'citation': "Old O, Jankowski J, Attwood S, Stokes C, Kendall C, Rasdell C, Zimmermann A, Massa MS, Love S, Sanders S, Deidda M, Briggs A, Hapeshi J, Foy C, Moayyedi P, Barr H; BOSS Trial Team. Barrett's Oesophagus Surveillance Versus Endoscopy at Need Study (BOSS): A Randomized Controlled Trial. Gastroenterology. 2025 Nov;169(6):1233-1243.e8. doi: 10.1053/j.gastro.2025.03.021. Epub 2025 Apr 1."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment. It is not yet known whether endoscopy every 2 years is more effective than endoscopy only as needed in finding esophageal cancer in patients with Barrett esophagus.\n\nPURPOSE: This randomized phase III trial is studying endoscopy every 2 years to see how well it works compared with endoscopy only as needed in monitoring patients with Barrett esophagus.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To establish whether endoscopic surveillance every 2 years or endoscopy at need only is superior in terms of overall survival and, if neither is superior, whether endoscopy at need only is non-inferior to surveillance every 2 years in patients with Barrett esophagus.\n\nSecondary\n\n* To estimate the cost-effectiveness of endoscopic surveillance every 2 years as compared to endoscopy at need only.\n* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the incidence of esophageal cancer, gastric or esophageal cancer, or all cancers.\n* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the time to diagnosis of esophageal adenocarcinoma.\n* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the stage of esophageal adenocarcinoma at diagnosis using TNM staging.\n* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of morbidity and mortality related to endoscopy, esophageal surgery, and other endoscopy-related interventions (e.g., ablation).\n* To establish whether there is a significant difference between endoscopic surveillance every 2 years or endoscopy at need only in terms of the frequency of endoscopy.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis (\\< 65 years vs ≥ 65 years), length of Barrett metaplasia segment including tongues (\\< 2 cm vs ≥ 2 cm and ≤ 3 cm vs \\> 3 cm and ≤ 8 cm vs \\> 8 cm), and newly diagnosed disease (defined as the date of endoscopy confirming Barrett metaplasia was within the past 4 months) (yes vs no). Patients are randomized to 1 of 2 intervention arms.\n\n* Arm I: Patients undergo surveillance endoscopy with quadrantic biopsies taken every 2 cm. Patients undergo endoscopy every 2 years for a total of 6 endoscopies over 10 years.\n* Arm II: Patients undergo endoscopy as needed over 10 years. All patients may undergo urgent endoscopy if they develop dysphagia, unexplained weight loss of \\> 7 lb, iron-deficiency anemia, recurrent vomiting, or worsening upper gastrointestinal symptoms.\n\nAll patients complete a questionnaire that includes a quality-of-life measure and questions about medication at baseline, every 2 years, and following key events (e.g., diagnosis of any cancer or high-grade dysplasia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed circumferential Barrett metaplasia meeting 1 of the following criteria:\n\n * At least 1 cm from the gastro-esophageal junction\n * At least a 2 cm non-circumferential tongue of Barrett metaplasia\n* Undergone endoscopy within the last 2 years to confirm Barrett metaplasia and exclude high-grade dysplasia and carcinoma\n* No known high-grade dysplasia or carcinoma\n\nPATIENT CHARACTERISTICS:\n\n* Resident of the United Kingdom\n* Informed of the risk of Barrett esophagus developing into esophageal cancer, either at the visit when the invitation letter is issued or on a documented previous occasion\n* Able to undergo endoscopy\n* No medical conditions that would make endoscopy difficult or hazardous\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00987857', 'briefTitle': 'Endoscopy Every 2 Years or Only as Needed in Monitoring Patients With Barrett Esophagus', 'organization': {'class': 'OTHER', 'fullName': 'Gloucestershire Hospitals NHS Foundation Trust'}, 'officialTitle': "Barrett's Oesophagus Two Yearly Surveillance Versus Endoscopy at Need: a Randomised Controlled Trial to Estimate Effectiveness and Cost-effectiveness Study (BOSS)", 'orgStudyIdInfo': {'id': 'NHS-GRH-HTA-05/12/01'}, 'secondaryIdInfos': [{'id': 'CDR0000649890', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'ISRCTN54190466'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2 yearly endoscopies', 'description': 'Two years endoscopies', 'interventionNames': ['Procedure: 2 yearly endoscopy', 'Procedure: comparison of screening methods', 'Procedure: diagnostic endoscopic procedure', 'Procedure: endoscopic biopsy', 'Procedure: endoscopic procedure', 'Procedure: quality-of-life assessment', 'Procedure: screening method']}, {'type': 'EXPERIMENTAL', 'label': 'endoscopy at need', 'description': 'Endoscopy only when patient reports symptoms', 'interventionNames': ['Procedure: 2 yearly endoscopy', 'Procedure: comparison of screening methods', 'Procedure: diagnostic endoscopic procedure', 'Procedure: endoscopic biopsy', 'Procedure: endoscopic procedure', 'Procedure: quality-of-life assessment', 'Procedure: screening method']}], 'interventions': [{'name': '2 yearly endoscopy', 'type': 'PROCEDURE', 'description': '2 yearly endoscopy versus endoscopy at need', 'armGroupLabels': ['2 yearly endoscopies', 'endoscopy at need']}, {'name': 'comparison of screening methods', 'type': 'PROCEDURE', 'description': '2 yearly endoscopy versus endoscopy at need', 'armGroupLabels': ['2 yearly endoscopies', 'endoscopy at need']}, {'name': 'diagnostic endoscopic procedure', 'type': 'PROCEDURE', 'description': '2 yearly endoscopy versus endoscopy at need', 'armGroupLabels': ['2 yearly endoscopies', 'endoscopy at need']}, {'name': 'endoscopic biopsy', 'type': 'PROCEDURE', 'description': '2 yearly endoscopy versus endoscopy at need', 'armGroupLabels': ['2 yearly endoscopies', 'endoscopy at need']}, {'name': 'endoscopic procedure', 'type': 'PROCEDURE', 'description': '2 yearly endoscopy versus endoscopy at need', 'armGroupLabels': ['2 yearly endoscopies', 'endoscopy at need']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'QOL aims to elicit any differences in QOL between 2 yearly endoscopy versus endoscopy at need', 'armGroupLabels': ['2 yearly endoscopies', 'endoscopy at need']}, {'name': 'screening method', 'type': 'PROCEDURE', 'description': 'All Barretts patients to be screened', 'armGroupLabels': ['2 yearly endoscopies', 'endoscopy at need']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}], 'overallOfficials': [{'name': 'Hugh Barr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gloucestershire Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gloucestershire Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Hugh Barr', 'investigatorFullName': 'Clive Stokes', 'investigatorAffiliation': 'Gloucestershire Hospitals NHS Foundation Trust'}}}}