Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-30 @ 3:50 AM
Study NCT ID:
NCT01311466
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2011-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver Transplantation and Uveal Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-20', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Over all survival', 'timeFrame': '1 year', 'description': 'Patient survival after livertransplantation'}]}, 'conditionsModule': {'keywords': ['Liver transplantation', 'Overall survival'], 'conditions': ['Uveal Malignant Melanoma']}, 'descriptionModule': {'briefSummary': 'Patients with uveal malignant melanoma with liver metastases have median survival of less than 12 months. There is no established treatment showing increased overall survival. The study will determine if liver transplantation will result in long term survival in patients with liver metastases from uveal malignant melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uveal malignant melanoma\n* Liver metastases\n* ECOG 0-1\n\nExclusion Criteria:\n\n* Extra hepatic disease\n* Previous other malignancy\n* Previous organ transplantation'}, 'identificationModule': {'nctId': 'NCT01311466', 'briefTitle': 'Liver Transplantation and Uveal Malignant Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Open Non-randomized Study to Assess the Benefit of Liver Transplantation in Patients With Liver Metastasis After Ocular Malignant Melanoma (Uveal Melanoma)', 'orgStudyIdInfo': {'id': 'S-06408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liver transplantation', 'description': 'The liver transplantation will be performed as described by the standard protocol, Liver Transplantation Protocol (Version 2006) at the Oslo University Hospital', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['Liver transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N0310', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Svein Dueland, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital, Radium hospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Svein Dueland', 'investigatorAffiliation': 'Oslo University Hospital'}}}}