Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04477720
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of De-identified Deceased HCC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537356', 'term': 'Metatropic dwarfism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-07-16', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '10 years', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCC, AFP, MTD, survival, NLR, PLR, Tumor Aggressiveness'], 'conditions': ['Survival']}, 'descriptionModule': {'briefSummary': 'De-identified deceased HCC patients who were not surgical candidates were evaluated for their clinical baseline characteristics associated with their survival. Baselines included tumor markers, blood counts and liver function tests and CAT-scan based tumor size and numbers and presence of portal vein thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting for HCC management', 'genderDescription': 'Yes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy-proven HCC\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04477720', 'briefTitle': 'Retrospective Analysis of De-identified Deceased HCC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Carr, Brian'}, 'officialTitle': 'HCC Observation Study', 'orgStudyIdInfo': {'id': 'BCarr'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carr, Brian', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}