Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-26 @ 10:54 PM
Study NCT ID:
NCT03759756
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2018-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-25', 'studyFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the diagnosis efficiency of the AI model', 'timeFrame': '12 months', 'description': 'the sensitivity, specificity and accuracy of the AI model'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artificial Intelligence', 'Optical Enhancement Endoscopy', 'Magnifying Endoscopy']}, 'descriptionModule': {'briefSummary': 'Esophageal squamous cell carcinoma is one of the most common malignant tumor of upper digestive tract. However, the detection rate and diagnosis accuracy of early esophageal squamous cell cancer is low. The aim of this study is to develop a computer-assisted diagnosis tool combining with optical magnifying endoscopy for early detection and accurate diagnosis of it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients who came to Qilu Hospital of Shandong University and received optical magnifying OE endoscopy examination', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high risk patients for esophageal cancer aged 18 years or older;\n* Histologically verified early esophageal squamous cell cancer.\n\nExclusion Criteria:\n\n* patients whose images of esophagus not suitable for the training, validation and testing the computer-assist diagnosis tool.'}, 'identificationModule': {'nctId': 'NCT03759756', 'briefTitle': 'Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Application of Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma During Optical Enhancement Magnifying Endoscopy', 'orgStudyIdInfo': {'id': '2018SDU-QILU-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AI visible group', 'description': 'the endoscopic novices analyzing the images can see the automatic diagnosis of AI during the process', 'interventionNames': ['Other: AI presentation']}, {'label': 'AI invisible group', 'description': 'the endoscopic novice analyzing the images can not see the automatic diagnosis of AI during the process', 'interventionNames': ['Other: no AI presentation']}], 'interventions': [{'name': 'AI presentation', 'type': 'OTHER', 'description': 'AI presentation means the automatic diagnosis information of AI and AI presentation means it is visible in the group.', 'armGroupLabels': ['AI visible group']}, {'name': 'no AI presentation', 'type': 'OTHER', 'description': 'AI presentation means the automatic diagnosis information of AI and no AI presentation means it is invisible in the group.', 'armGroupLabels': ['AI invisible group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Yanqing Li, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}