Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-06 @ 10:21 AM
Study NCT ID:
NCT00178893
Status:
UNKNOWN
Last Update Posted:
2019-04-18
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatocellular Research Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Hepatocytes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatocytes']}, 'descriptionModule': {'briefSummary': 'This is a registry of human hepatocytes (liver cells) for research purposes.', 'detailedDescription': 'Patients scheduled for partial hepatectomy/liver surgery are asked permission to use their discarded liver tissue for purposes of studying:\n\n1. how drugs/medicines affect the liver and\n2. the effects of storing liver cells in the cold or freezing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient having liver resection operation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons undergoing partial hepatectomy/liver surgery for any reason.\n\nExclusion Criteria:\n\n* Persons with known HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)\n* A diagnosis of hepatocellular carcinoma without negative serologies\n* A diagnosis of cholangiocarcinoma, where the total bilirubin has ever been greater or equal to 3.0\n* The presence of a biliary drainage tube\n* Active sepsis'}, 'identificationModule': {'nctId': 'NCT00178893', 'briefTitle': 'Hepatocellular Research Registry', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'CellzDirect: Hepatocellular Research Registry', 'orgStudyIdInfo': {'id': '040220'}}, 'contactsLocationsModule': {'locations': [{'zip': '37232-4753', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carla M Ramsey, RN, BSN', 'role': 'CONTACT', 'email': 'carla.thomas@vanderbilt.edu', 'phone': '615-936-0834'}, {'name': 'Sunil K Geevarghese, MD, MSCI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Carla M Ramsey, RN, BSN', 'role': 'CONTACT', 'email': 'carla.thomas@Vanderbilt.edu', 'phone': '615-936-0834'}, {'name': 'Claudia Medlin', 'role': 'CONTACT', 'email': 'claudia.medlin@vanderbilt.edu', 'phone': '615-936-2573'}], 'overallOfficials': [{'name': 'Sunil K Geevarghese, MD, MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSCI', 'investigatorFullName': 'Sunil Geevarghese', 'investigatorAffiliation': 'Vanderbilt University'}}}}