Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 10:10 PM
Study NCT ID:
NCT00728650
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2008-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Review of Malignant Liver Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-06', 'studyFirstSubmitDate': '2008-08-01', 'studyFirstSubmitQcDate': '2008-08-01', 'lastUpdatePostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'lifetime'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'lifetime'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'colorectal carcinoma metastatic to liver', 'primary liver cancer'], 'conditions': ['Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '10400029', 'type': 'RESULT', 'citation': 'Curley SA, Izzo F, Delrio P, Ellis LM, Granchi J, Vallone P, Fiore F, Pignata S, Daniele B, Cremona F. Radiofrequency ablation of unresectable primary and metastatic hepatic malignancies: results in 123 patients. Ann Surg. 1999 Jul;230(1):1-8. doi: 10.1097/00000658-199907000-00001.'}]}, 'descriptionModule': {'briefSummary': 'This study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.', 'detailedDescription': "Subjects will be identified by diagnosis and procedure codes from a university surgical practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of both the clinic and hospital charts. In addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. Treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. Of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. Subjects were not exposed to risk beyond that posed by the recommended treatment. All treatments were within the scope of standard medical care. The primary investigator has no knowledge of the treatments chosen for the patients he did not manage. The subject's referring physician may be contacted to obtain follow-up data on the subject. The follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary or metastatic hepatic malignancies\n\nExclusion Criteria:\n\n* Patients not diagnosed with primary or metastatic hepatic malignancies'}, 'identificationModule': {'nctId': 'NCT00728650', 'briefTitle': 'A Retrospective Review of Malignant Liver Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'A Retrospective Review of Malignant Liver Tumors', 'orgStudyIdInfo': {'id': 'TAB11119'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': 'Patients with primary or metastatic hepatic malignancies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The University of Oklahoma College of Medicine, Tulsa - Department of Surgery', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Thomas A Broughan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma-Tulsa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}