Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-25 @ 8:36 AM
Study NCT ID:
NCT02182804
Status:
COMPLETED
Last Update Posted:
2020-08-28
First Post:
2014-07-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mpkus1@gmail.com', 'phone': '6622564000', 'title': 'Dr. Piyapan Prueksapanich', 'phoneExt': '81001', 'organization': 'Division of Gastroenterology. Department of Medicine. Faculty of Medicine. Chulalongkorn University.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "This was a pilot study and the sample size was small. We did not randomly assign the order of dNBI and pCLE. The unwashed Lugol's stain significantly influenced the observation of IPCL structure on dNBI study."}}, 'adverseEventsModule': {'timeFrame': 'Intraprocedural.', 'eventGroups': [{'id': 'EG000', 'title': 'Study Arm', 'description': "Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions.", 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 1, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bleeding', 'notes': 'One patient developed bleeding after biopsy and was successfully treated with endoscopic clipping.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': "Lugol's voiding lesion", 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Arm', 'description': "Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions."}], 'classes': [{'title': 'pCLE', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '97'}]}]}, {'title': 'dNBI', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '85'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an expected average of 2 weeks', 'description': "Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters.", 'unitOfMeasure': 'Percentage of accuracy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': "Lugol's voiding lesion", 'denomUnitsSelected': "Lugol's voiding lesion", 'populationDescription': "Twenty-one Lugol's voiding lesions larger than 5mm were detected in 12 patients."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Arm', 'description': "Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'There were 631 patients with a previous history of head and neck cancer in the 10-year record. Of the 631 patients, 587 were excluded for the following reasons: patients could not be contacted (n=458), death (n=72), esophageal obstruction or stricture, previous esophageal surgery (n=34), and patients who refused to participate (n=23).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Arm', 'description': "Probe-based confocal laser endomicroscopy and narrow band imaging with magnification in esophageal Lugol's voiding lesions."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2014-07-01', 'resultsFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-13', 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'an expected average of 2 weeks', 'description': "Diagnostic performance of the pCLE and M-NBI in Lugol's voiding lesions size larger than 5 millimeters."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Confocal Laser Endomicroscopy', 'Narrow Band Imaging', 'Lugol Chromoendoscopy', 'Esophageal Neoplasm', 'Head and Neck Cancer'], 'conditions': ['Esophageal Neoplasms']}, 'descriptionModule': {'briefSummary': "This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 20 years\n* Having histological-confirmed diagnosis of head and neck cancer\n* Having no esophageal symptoms\n\nExclusion Criteria:\n\n* Having index cancer of nasopharynx\n* History of esophageal surgery\n* Having esophageal stricture or obstruction\n* Having esophageal varices\n* Known case of esophageal cancer\n* Uncorrectable coagulopathy and thrombocytopenia\n* Pregnancy\n* Thyrotoxicosis\n* Creatinine clearance less than 30 ml/min\n* Allergy to iodine or fluorescein.'}, 'identificationModule': {'nctId': 'NCT02182804', 'briefTitle': 'A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'King Chulalongkorn Memorial Hospital'}, 'officialTitle': "Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.", 'orgStudyIdInfo': {'id': 'RP008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'probe-based confocal laser endomicroscopy narrow band imaging with magnification', 'interventionNames': ['Device: Olympus', 'Device: Cellvizio']}], 'interventions': [{'name': 'Olympus', 'type': 'DEVICE', 'description': 'narrow band imaging with magnification', 'armGroupLabels': ['Study']}, {'name': 'Cellvizio', 'type': 'DEVICE', 'description': 'probe-based confocal laser endomicroscopy', 'armGroupLabels': ['Study']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rapat Pittayanon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Chulalongkorn Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Chulalongkorn Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chulalongkorn University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist', 'investigatorFullName': 'Rapat Pittayanon', 'investigatorAffiliation': 'King Chulalongkorn Memorial Hospital'}}}}