Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 5:04 PM
Study NCT ID:
NCT01132560
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2010-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2010-05-26', 'studyFirstSubmitQcDate': '2010-05-26', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ipsilateral local failure (first event of invasive or DCIS recurrence)', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Contralateral breast cancer (invasive or DCIS)', 'timeFrame': '1 month'}]}, 'conditionsModule': {'keywords': ['ductal breast carcinoma in situ'], 'conditions': ['Breast 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 research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.', 'detailedDescription': 'OBJECTIVES:\n\n* To validate the prognostic utility of a new ductal breast carcinoma in situ (DCIS) genomic score and the Oncotype DX Recurrence Score® assay in tissue samples from patients with DCIS enrolled on clinical trial ECOG-E5194.\n\nOUTLINE: RNA extracted from archived tissue samples are analyzed for gene expression profile by Oncotype DX Recurrence Score® assay (a reverse transcriptase-PCR-based assay).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples submitted for research from patient enrolled on E5194', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of ductal breast carcinoma in situ\n* Enrolled on clinical trial ECOG-E5194\n\n * Local surgery without radiotherapy\n * Treated or not treated with tamoxifen\n* Available tissue samples\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT01132560', 'briefTitle': 'Biomarkers in Tissue Samples From Patients With Ductal Breast Carcinoma in Situ', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'A Correlative Science Study for ECOG E5194', 'orgStudyIdInfo': {'id': 'CDR0000671157'}, 'secondaryIdInfos': [{'id': 'ECOG-E5194T1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'RNA analysis', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'reverse transcriptase-polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lawrence J. Solin, MD, FACR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ECOG-ACRIN Cancer Research Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}