Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT01482520
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2011-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genotypes', 'timeFrame': '36months', 'description': 'To define genotypes of HCC and RCC patients who will likely to response to molecular targeted therapy.\n\nTo define genotypes associated with adverse events from molecular targeted.\n\nTo identify genotypes which will predict survival or disease-free survival following molecular targeted therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.\n\nNo additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only.\n\nBlood samples (10 cc in volume) will be collected from all study participants once they provided written informed consent form. DNA will be extracted from peripheral blood samples using DNA isolation kit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.\n\nOnce the patient signed written informed consent, two bottles of 5 cc blood will be drawn and subsequently extracted DNA and serum will be stored until genetic analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study'}, 'identificationModule': {'nctId': 'NCT01482520', 'briefTitle': 'Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '2008-06-050'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal cell carcinoma'}, {'label': 'Hepatocellular carcinoma patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology', 'investigatorFullName': 'Ho Yeong Lim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}