Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT03285867
Status:
UNKNOWN
Last Update Posted:
2018-04-30
First Post:
2017-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Stiffness Measurement (LSM) in Predicting Progress of Liver Fibrosis After TACE for Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D017093', 'term': 'Liver Failure'}], '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'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope)', 'timeFrame': 'within 1 week pre-TACE and 1 week post-TACE', 'description': 'The investigators will investigate the value of LSM( kpa) by machine of FibroScan ( produced by France Echo).\n\nThe investigators will record LSMs before and after each procedure of TACE. The investigators will calculate the change of LSMs of each participants.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Liver Failure']}, 'descriptionModule': {'briefSummary': 'Objective: To evaluate the efficacy of preoperative liver stiffness measurement(LSM) by FibroScan in predicting the progress of liver fibrosis and prognosis after transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC).\n\nBackground: Progress of liver fibrosis and liver failure and related poor prognosis after TACE which are not completely predictable by current method including Child-Pugh Classification. LSM is used to calculate the degree of liver fibrosis and is affected by several liver injury, e.g. elevated Alanine aminotransferase（ALT）, Aspartate transaminase(AST) and Bilirubin et al. The investigators assume that LSM could be use to predict progress of liver fibrosis and adverse effects after TACE in HCC.\n\nMethods: At least 200 patients will be recruited in this prospective observational study with preoperative LSM, demographic, laboratory, radiological and other treatment-related factors. Participants will be followed up till death or to the end of study no matter the liver failure occurs or not. Data will be analyzed to build a mathematical predicting model.\n\nResearch hypothesis：TACE is related to progress of liver fibrosis and a mathematical model with LSM is able to predict the risk of liver failure and prognosis in HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted to our department', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age：18-80\n* HCC diagnosed by pathologist or physician according to Guidelines\n* Chronic Hepatitis B (CHB) background\n* receive at least 1 TACE\n* volunteer to join the research\n\nExclusion Criteria:\n\n* massive lesion with insufficient liver left for LSM examination\n* associated with other liver diseases: Chronic Hepatitis C(CHC),Autoimmune Hepatitis(AIH),Wilson's disease.\n* severe obesity(BMI\\>28)\n* pregnancy\n* other inappropriate situation defined by investigators."}, 'identificationModule': {'nctId': 'NCT03285867', 'briefTitle': 'Liver Stiffness Measurement (LSM) in Predicting Progress of Liver Fibrosis After TACE for Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Value of Liver Stiffness Measurement (LSM) in Predicting the Progress of Liver Fibrosis After Transcatheter Arterial Chemoembolization (TACE) for Hepatocellular Carcinoma, an Observational Study', 'orgStudyIdInfo': {'id': 'liuhy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCC received TACE', 'description': 'observational study set only one group with HCC received TACE', 'interventionNames': ['Procedure: TACE']}], 'interventions': [{'name': 'TACE', 'type': 'PROCEDURE', 'description': 'transcatheter arterial chemoembolization', 'armGroupLabels': ['HCC received TACE']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'wang kunyuan', 'role': 'CONTACT', 'email': '390671613@qq.com', 'phone': '0086-020-62787430'}, {'name': 'liu hongyan', 'role': 'CONTACT', 'email': 'liuhongyan205628@163.com', 'phone': '0086-020-62787631'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}