Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT01431703
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2011-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shenyufeng303@gmail.com', 'phone': '86021-34506250', 'title': 'Dr Ge zhi zheng', 'organization': 'Shanghai Jiaotong university'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'NBI With Magnification', 'description': 'Patients with lesions diagnosed by Sano classification using NBI with magnification', 'otherNumAtRisk': 326, 'otherNumAffected': 0, 'seriousNumAtRisk': 326, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NBI With Magnification', 'description': 'Patients with lesions diagnosed by Sano classification using NBI with magnification'}], 'classes': [{'title': 'Accuracy', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '97.1'}]}]}, {'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.9'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '95.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NBI With Magnification', 'description': 'Patients with lesions diagnosed by Sano classification using NBI with magnification'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NBI With Magnification', 'description': 'Patients with lesions diagnosed by Sano classification using NBI with magnification'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '229', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '326', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'if the lesion is neoplastic or sm deeper cancer, we just take biopsy.If the lesion is adenomatous or sm1-2 cancer,we do polypectomy, EMR or ESD to get the specimen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-08', 'studyFirstSubmitDate': '2011-09-08', 'resultsFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-08', 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions', 'timeFrame': 'For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['narrow band imaging', 'learning curve', 'colorectal', 'differential diagnosis', 'with colorectal lesion', 'NBI with magnification'], 'conditions': ['Colorectal Lesion']}, 'descriptionModule': {'briefSummary': 'It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.', 'detailedDescription': 'It is very useful to use narrow-band imaging and Sano CP analysis in the differential diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of NBI can have effective and stable diagnostic accuracy after using NBI with magnification to diagnose 15 target and non-target lesions respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'academic hospital endoscopist of digestive department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 16 to 85\n* Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions\n\nExclusion Criteria:\n\n* Unwilling to consent\n* Had surgery of colorectal tumors\n* Using NSAIDS\n* Diagnosed or suspected IBD\n* Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease'}, 'identificationModule': {'nctId': 'NCT01431703', 'briefTitle': 'The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions', 'orgStudyIdInfo': {'id': 'rjyyxhk0923'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhizheng Ge', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine', 'investigatorFullName': 'Zhizheng Ge', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}