Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-21 @ 6:49 PM
Study NCT ID:
NCT02480933
Status:
UNKNOWN
Last Update Posted:
2017-11-28
First Post:
2015-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 768}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-24', 'studyFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Silent breast cancer prevalence', 'timeFrame': '2 years', 'description': 'To define the existing disease that did not caused death in both sexes'}], 'secondaryOutcomes': [{'measure': 'Silent breast cancer prevalent molecular profile', 'timeFrame': '2 years', 'description': 'To identify those molecular subgroups of the disease that remain silent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Female Breast Cancer', 'Male Breast Cancer']}, 'referencesModule': {'availIpds': [{'id': 'https://doi.org/10.3892/mco.20', 'url': 'http://www.spandidos-publications.com/mco', 'type': 'Study Protocol', 'comment': 'feasibility of the protocol paper'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to define silent breast cancer prevalence in both sexes and will be held by biopsies performed in imaging suspicious areas of the breast (ecography and mammography) in cadavers without known breast cancer.', 'detailedDescription': 'Cadavers of both sexes are going to be submitted to bilateral mastectomy. The specimens are going to be examined by palpation, ecography and mammography and all areas with (Breast Imaging Reporting and Data System) BI-RADS classification \\>= 3 are going to be biopsied.\n\nBiopsy specimens are going to be processed by the pathology department and cancers are going to be identified and classified by their molecular type.\n\nThe investigators intend to know which is the disease reservoir in various ages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male cadavers above 40 years\n\nExclusion Criteria:\n\n* Known breast cancer\n* Breast tissue accidental damage'}, 'identificationModule': {'nctId': 'NCT02480933', 'acronym': 'SISYPHUS', 'briefTitle': 'Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centro Hospitalar Lisboa Ocidental'}, 'officialTitle': 'Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens', 'orgStudyIdInfo': {'id': 'CentroHLO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'female cadavers', 'description': 'female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy', 'interventionNames': ['Procedure: Bilateral mastectomy', 'Other: Biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Male cadavers', 'description': 'male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy', 'interventionNames': ['Procedure: Bilateral mastectomy', 'Other: Biopsy']}], 'interventions': [{'name': 'Bilateral mastectomy', 'type': 'PROCEDURE', 'description': 'Bilateral mastectomy and imaging study of cadaveric breasts', 'armGroupLabels': ['Male cadavers', 'female cadavers']}, {'name': 'Biopsy', 'type': 'OTHER', 'description': 'Biopsy of BI-RADS 3 and superior lesions', 'armGroupLabels': ['Male cadavers', 'female cadavers']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar Lisboa Ocidental', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Instituto Nacional de Medicina Legal e Ciências Forenses, Delegação do Sul', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Zacharoula Sidiropoulou MD, MSc, Principal Investigator, General Surgery Assistent', 'investigatorFullName': 'Zacharoula Sidiropoulou', 'investigatorAffiliation': 'Centro Hospitalar Lisboa Ocidental'}}}}