Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT00899002
Status:
WITHDRAWN
Last Update Posted:
2013-04-10
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055028', 'term': 'Comparative Genomic Hybridization'}, {'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D013058', 'term': 'Mass Spectrometry'}], 'ancestors': [{'id': 'D020732', 'term': 'Cytogenetic Analysis'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D025202', 'term': 'Molecular Diagnostic Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA will be extracted from the tissue samples and analyzed for molecular signatures, i.e., genomic and proteomic analyses.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-08', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2013-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of proteomic profiles and molecular pathways involved in tumor progression', 'timeFrame': 'After collection of tissue samples', 'description': 'Genomic analysis, targeted gene mutation analysis, immunohistochemistry, and mass spectrometry will be employed to identify proteomic profiles and specific molecular pathways involved in tumor progression of fibrolamellar carcinoma and hepatocellular carcinoma'}], 'secondaryOutcomes': [{'measure': 'Association between fibrolamellar carcinoma and hepatocellular carcinoma in terms of molecular aberrations and clinicopathologic features', 'timeFrame': 'After molecular analysis of tissue and after collection of clinicopathologic data', 'description': 'Compare and contrast fibrolamellar carcinoma with hepatocellular carcinoma in terms of the molecular differences, tissue pathologies, and medical histories.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['childhood hepatocellular carcinoma', 'childhood liver cancer', 'adult primary liver cancer', 'adult primary hepatocellular carcinoma'], 'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To characterize, at a molecular level, archived samples of tissue from young patients with fibrolamellar carcinoma and hepatocellular carcinoma in non-cirrhotic livers matched for age and sex.\n* To perform genomic analysis on these tissue samples using array comparative genomic hybridization.\n* To perform targeted gene mutation analysis on these samples by PCR.\n* To perform proteomic profiling on fixed tissues in these samples by various proteomic methods, including IHC and mass spectrometry.\n* To look for association between molecular aberrations and clinicopathologic features in these samples.\n\nOUTLINE: Archived tissue samples are collected from the pathology department at Vanderbilt University Medical Center and from the Mayo Clinic in Rochester, Minnesota. Tissue samples are analyzed by genomic analysis using array comparative genomic hybridization, target gene mutation analysis by PCR, and proteomic profiling on fixed tissues using various proteomic methods, including IHC and mass spectrometry. Samples are also examined for association between molecular aberrations and clinicopathologic features found in each disease.\n\nClinical patient data (i.e., age, sex, race, date of diagnosis, risk factors, histology, surgical staging, follow-ups, date of death, and adjuvant therapy) are also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sample collection: 20 cases of fibrolamellar carcinoma and 20 hepatocellular carcinomas.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDISEASE CHARACTERISTICS:\n\n* Diagnosis of fibrolamellar carcinoma or hepatocellular carcinoma in a non-cirrhotic liver\n* Archived tumor specimens available for analysis from Vanderbilt University or Mayo Clinic\n\nExclusion Criteria:\n\n* Not specified\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00899002', 'briefTitle': 'Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Molecular Analysis of Liver Cancer', 'orgStudyIdInfo': {'id': 'VICC GI 0611'}, 'secondaryIdInfos': [{'id': 'VU-VICC-GI-0611'}, {'id': 'VU-VICC-060479'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'comparative genomic hybridization', 'type': 'GENETIC', 'otherNames': ['None specified']}, {'name': 'molecular genetic technique', 'type': 'GENETIC', 'otherNames': ['none noted']}, {'name': 'mutation analysis', 'type': 'GENETIC', 'otherNames': ['none noted']}, {'name': 'polymerase chain reaction', 'type': 'GENETIC', 'otherNames': ['none specified'], 'description': 'Not noted'}, {'name': 'proteomic profiling', 'type': 'GENETIC', 'otherNames': ['none noted']}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'otherNames': ['none specified'], 'description': 'not noted'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'otherNames': ['none specified'], 'description': 'not noted'}, {'name': 'mass spectrometry', 'type': 'OTHER', 'otherNames': ['none specified'], 'description': 'not noted'}, {'name': 'medical chart review', 'type': 'OTHER', 'otherNames': ['none specified'], 'description': 'not noted'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laura Goff, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Medical Oncologist', 'investigatorFullName': 'Laura W. Goff, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}