Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT03069833
Status:
UNKNOWN
Last Update Posted:
2017-03-28
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003936', 'term': 'Diagnosis, Computer-Assisted'}], 'ancestors': [{'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-25', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, Specificity, False Positive, False Negative', 'timeFrame': 'Duration between endoscopic diagnosis and pathologic diagnosis is about one week', 'description': 'Diagnostic accuracy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Polyp']}, 'descriptionModule': {'briefSummary': 'An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nthe same as colonoscopy\n\nExclusion Criteria:\n\nthe same as colonoscopy'}, 'identificationModule': {'nctId': 'NCT03069833', 'briefTitle': 'Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination', 'orgStudyIdInfo': {'id': '2-105-05-061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computer-aided diagnosis', 'interventionNames': ['Diagnostic Test: Computer-aided diagnosis']}, {'type': 'NO_INTERVENTION', 'label': 'traditional diagnosis'}], 'interventions': [{'name': 'Computer-aided diagnosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'computer-aided diagnosis to assist colonoscopists', 'armGroupLabels': ['Computer-aided diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Peng-Jen Chen, MD', 'role': 'CONTACT', 'email': 'endoscopy@ndmctsgh.edu.tw', 'phone': '+886-87923311', 'phoneExt': '88056'}], 'facility': 'Endoscopy Center, Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Peng-Jen Chen, MD', 'role': 'CONTACT', 'email': 'endoscopy@ndmctsgh.edu.tw', 'phone': '+886-87923311', 'phoneExt': '88056'}], 'overallOfficials': [{'name': 'Peng-Jen Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital, National Defense Medical Center, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Endoscopy Center', 'investigatorFullName': 'Peng-Jen Chen', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}