Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT03904667
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Watson for Oncology in Hepatocellular Carcinoma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-04-04', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 years', 'description': 'Survival time without tumor after hepatectomy'}], 'primaryOutcomes': [{'measure': 'Operative outcomes', 'timeFrame': 'intraoperative', 'description': 'Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.'}], 'secondaryOutcomes': [{'measure': 'Postoperative survival', 'timeFrame': '3 years', 'description': 'Survival after hepatectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Watson artificial intelligence', 'hepatocellular carcinoma', 'surgical decisions'], 'conditions': ['Liver Resection']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the surgical decisions of Watson artificial intelligence in patients with hepatocellular carcinoma.', 'detailedDescription': 'Hepatectomy is an effective treatment for patients with hepatocellular carcinoma, but liver failure after hepatectomy may lead to increased postoperative mortality. Therefore, it is very important to make preoperative surgical decisions, evaluate the safety of the operation and identify which patients are likely to suffer from liver failure. The artificial intelligence platform developed by IBM Watson for Watson tumor treatment decisions can provide treatment decisions and corresponding theoretical basis to guide surgical decisions based on the key clinical data of liver cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 150 hepatocellular carcinoma patients admitted to the department of hepatobiliary surgery of zhujiang hospital of southern medical university from January 2017 to December 2021 were selected and divided into experimental group and control group', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years≤ Age ≤80 years\n2. Compling with the diagnosis criteria of complex hepatic carcinoma.\n3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled\n4. Preoperative liver function is Child - Pugh grade A or B.\n5. The patients are volunteered for the study.\n\nExclusion Criteria:\n\n1. Patients with mental illness.\n2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)\n3. The patients refused to take part in the study.\n4. There are other co-existed malignant tumors.\n5. Benign liver diseases"}, 'identificationModule': {'nctId': 'NCT03904667', 'briefTitle': 'Application of Watson for Oncology in Hepatocellular Carcinoma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Application of Watson for Oncology in Hepatocellular Carcinoma Surgery', 'orgStudyIdInfo': {'id': '20170101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Watson on oncology recommends surgery', 'interventionNames': ['Other: Watson on oncology surgery decision evaluation']}, {'label': 'Watson on oncology does not recommend surgery', 'interventionNames': ['Other: Watson on oncology surgery decision evaluation']}], 'interventions': [{'name': 'Watson on oncology surgery decision evaluation', 'type': 'OTHER', 'description': 'Watson on oncology surgery decision evaluation. The system acquires and evaluates a large amount of structured and unstructured data from previous medical records through machine learning and natural language processing, and USES algorithms to select treatment options as the best choice for a particular patient.', 'armGroupLabels': ['Watson on oncology does not recommend surgery', 'Watson on oncology recommends surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510282', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}