Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT00965627
Status:
COMPLETED
Last Update Posted:
2009-08-28
First Post:
2009-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biology of Thymic Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013945', 'term': 'Thymoma'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'paraffin-embedded tumor specimens of patients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-27', 'studyFirstSubmitDate': '2009-08-06', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary objective: to evaluate the presence of genetic alterations and specific potential therapy targets.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Secondary objective: to correlate the biological characteristics with clinical characteristics and survival data of patients.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thymoma']}, 'referencesModule': {'references': [{'pmid': '23444221', 'type': 'DERIVED', 'citation': 'Petrini I, Wang Y, Zucali PA, Lee HS, Pham T, Voeller D, Meltzer PS, Giaccone G. Copy number aberrations of genes regulating normal thymus development in thymic epithelial tumors. Clin Cancer Res. 2013 Apr 15;19(8):1960-71. doi: 10.1158/1078-0432.CCR-12-3260. Epub 2013 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective analysis of biological characteristics of thymoma and thymic carcinoma patients.', 'detailedDescription': 'The aim of the present study is to investigated the genetic alterations in tumor samples of a series of all WHO-defined subtypes of thymoma patients using high resolution microarray- comparative genomic hybridization (CGH) followed by hierarchical cluster analyses of the data to identify specific patterns of genetic aberrations and genes associated with each subtype. Moreover, tumor samples will be also investigated for some specific potential therapy targets by immunoistichemistry, mutation analysis, and fluorescence in situ hybridization (FISH) analysis. All these biological data will be correlated with clinical patients characteristics and survival data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thymoma and thymic carcinoma patients will be retrospectively analyzed. Patients will be selected based on the availability of tumor tissue.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Availability of tumor tissue and patients with thymoma and thymic carcinoma\n\nExclusion Criteria:\n\n* NON Availability of tumor tissue and patients with thymoma and thymic carcinoma'}, 'identificationModule': {'nctId': 'NCT00965627', 'briefTitle': 'Biology of Thymic Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Biological Analysis of a Series of Thymoma and Thymic Carcinoma: Genetic Aberrations and Potential Therapy Targets.', 'orgStudyIdInfo': {'id': 'ONC/OSS-01/2008'}}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Armando Santoro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Clinico Humanitas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Armando Santoro, MD', 'oldOrganization': 'Istituto Clinico Humanitas'}}}}