Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01711502
Status:
COMPLETED
Last Update Posted:
2014-01-30
First Post:
2012-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiology and Management of Metastatic Breast Cancer
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-29', 'studyFirstSubmitDate': '2012-10-18', 'studyFirstSubmitQcDate': '2012-10-18', 'lastUpdatePostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage', 'timeFrame': 'At 12 and 18 months after diagnosis'}], 'secondaryOutcomes': [{'measure': 'The progression free survival (PFS) rates', 'timeFrame': 'At 12 and 18 months after diagnosis'}, {'measure': 'The progression free survival (PFS) time', 'timeFrame': 'At 18 months after diagnosis'}, {'measure': 'Time to progression (TTP)', 'timeFrame': 'At 18 months after diagnosis'}, {'measure': 'The clinical and pathological characteristics of newly diagnosed MBC patients', 'timeFrame': 'At 18 months after diagnosis'}, {'measure': 'The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients', 'timeFrame': 'At 18 months after diagnosis'}, {'measure': 'Health care utilization associated with the disease in Romania', 'timeFrame': 'At 18 months after diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic breast cancer,', 'epidemiology,', 'retrospective cohort'], 'conditions': ['Breast Cancer Nos Metastatic Recurrent']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.', 'detailedDescription': 'Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A retrospective cohort study'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients diagosed with metastatic breast cance, age \\> 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged 18 years and over Diagnosis of breast cancer according to ICD-10 diagnostic criteria with confirmed metastasis\n* Confirmed diagnosis between 1st July 2010 - 30th June 2011\n* Female patient managed for her disease at the same setting where final diagnosis of MBC was performed\n\nExclusion Criteria:\n\n* History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer)'}, 'identificationModule': {'nctId': 'NCT01711502', 'briefTitle': 'Epidemiology and Management of Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'NIS-ORO-XXX-2012/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female patients diagosed with metastatic breast cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baia Mare', 'country': 'Romania', 'facility': 'Doina Coste Gherasim', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Daniel Ciurescu', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Dana Lucia Stanculeanu', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Dragos Median', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Mircea Dediu', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Rodica Tudor', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Alexandru Eniu', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Gabriela Morar Bolba', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Bena Sandra', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Nelly Cherciu', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Diana Petroiu', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Târgovişte', 'country': 'Romania', 'facility': 'Simona Angelescu', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Cristina Oprean', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Stefan Curescu', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Vaslui', 'country': 'Romania', 'facility': 'Cristina Elen Pirau', 'geoPoint': {'lat': 46.63333, 'lon': 27.73333}}], 'overallOfficials': [{'name': 'Dediu Mrcea, SENIOR PHYSICIAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bucharest Institute of Oncology'}, {'name': 'Alexandru Eniu, SENIOR PHYSICIAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cluj Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}