Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 4:29 PM
Study NCT ID:
NCT01227733
Status:
UNKNOWN
Last Update Posted:
2014-01-22
First Post:
2010-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Genomic and Genetic Analysis of Paired Primary Breast - Metastatic Tumor Specimens Using High-throughput Platforms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2010-10-21', 'studyFirstSubmitQcDate': '2010-10-21', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20339913', 'type': 'BACKGROUND', 'citation': 'Barrios CH, Liu MC, Lee SC, Vanlemmens L, Ferrero JM, Tabei T, Pivot X, Iwata H, Aogi K, Lugo-Quintana R, Harbeck N, Brickman MJ, Zhang K, Kern KA, Martin M. Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer. Breast Cancer Res Treat. 2010 May;121(1):121-31. doi: 10.1007/s10549-010-0788-0. Epub 2010 Mar 26.'}, {'pmid': '20430905', 'type': 'BACKGROUND', 'citation': 'Lim YW, Goh BC, Wang LZ, Tan SH, Chuah BYS, Lim SE, Iau P, Buhari SA, Chan CW, Sukri NB, Cordero MT, Soo R, Lee SC. Pharmacokinetics and pharmacodynamics of docetaxel with or without ketoconazole modulation in chemonaive breast cancer patients. Ann Oncol. 2010 Nov;21(11):2175-2182. doi: 10.1093/annonc/mdq230. Epub 2010 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'Adequate quality and quantity of RNA may be extracted from paraffin-embedded tumor blocks for gene expression analysis. This has clinical relevance as gene expression signatures may then be profiled using archival tumor blocks, which are more readily available than frozen tissues.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 10 archival breast tumor blocks will be obtained from the Department of Pathology, NUH - half of these blocks will be from patients who were diagnosed before year 2000, and the other half of the blocks will be from patients diagnosed between year 2000-2005 (control specimens). Basic tumor and patient information will be collected without patient identifiers - grade, stage, ER/PR/HER2 status, treatment received, outcome data. 8-10 ten-micron sections will be cut from each tumor block. RNA will be extracted from the tumor sections using the Roche High Pure FFPE RNA Micro Kit. RNA will be profiled using the Illumina Veracode assay and the Affymetrix Quantigene assay. RNA extraction and gene expression profiling will be performed by collabroators at the Genome Institute of Singapore.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNo participants are involved.\n\nExclusion Criteria:\n\nNo participants are involved.'}, 'identificationModule': {'nctId': 'NCT01227733', 'briefTitle': 'Comparative Genomic and Genetic Analysis of Paired Primary Breast - Metastatic Tumor Specimens Using High-throughput Platforms', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'orgStudyIdInfo': {'id': 'BR06/25/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Tumor', 'description': 'Breast Tumor Blocks', 'interventionNames': ['Other: Breast Tumor Blocks']}], 'interventions': [{'name': 'Breast Tumor Blocks', 'type': 'OTHER', 'armGroupLabels': ['Breast Tumor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}}}}