Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 1:07 AM
Study NCT ID:
NCT01612650
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2012-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008327', 'term': 'Mammography'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1069}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine the benefit of tomosynthesis for diagnosis', 'timeFrame': '30 months', 'description': 'number of avoided focused cliches and ultrasound, after tomosynthesis analysis'}], 'secondaryOutcomes': [{'measure': 'determine best incidence of realization', 'timeFrame': '30 months', 'description': 'face, medial side or oblique'}, {'measure': 'measurement of breast irradiation', 'timeFrame': '30 months', 'description': 'comparison of tomosynthesis irradiation and focused cliches irradiation'}, {'measure': 'evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast', 'timeFrame': '30 months'}, {'measure': 'number of additional cancer detected by tomosynthesis', 'timeFrame': '30 months', 'description': 'number of breast cancer detected through tomosynthesis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'surveillance', 'diagnosis', '2D mammography', '3D mammography'], 'conditions': ['Breast Cancer', '2D Mammography', '3D Mammography']}, 'descriptionModule': {'briefSummary': 'This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly\n* age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)\n* breast size suitable for detector size\n* possible prior mastectomy\n* security social covered\n* signed informed consent\n\nExclusion Criteria:\n\n* breast implant\n* high genetic risk (mutation)\n* under justice measures\n* breast feeding or pregnant woman'}, 'identificationModule': {'nctId': 'NCT01612650', 'acronym': 'TOMOSEIN', 'briefTitle': 'Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis', 'orgStudyIdInfo': {'id': 'TOMOSEIN-1104'}, 'secondaryIdInfos': [{'id': '2011-002051-34', 'type': 'OTHER', 'domain': 'IDRCB number (ANSM)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'breast cancer histologically proven', 'description': 'Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment', 'interventionNames': ['Device: tomosynthesis', 'Device: 2D mammography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'surveillance of a treated breast cancer', 'description': 'surveillance of patient already treated for breast cancer must have annual mammography', 'interventionNames': ['Device: tomosynthesis', 'Device: 2D mammography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diagnosis of a detected anomaly', 'description': 'patient addressed for diagnosis of a detected anomaly', 'interventionNames': ['Device: tomosynthesis', 'Device: 2D mammography']}], 'interventions': [{'name': 'tomosynthesis', 'type': 'DEVICE', 'description': '2 incidences 3D numeric mammography', 'armGroupLabels': ['breast cancer histologically proven', 'diagnosis of a detected anomaly', 'surveillance of a treated breast cancer']}, {'name': '2D mammography', 'type': 'DEVICE', 'description': '2 incidences 2D analogic mammography', 'armGroupLabels': ['breast cancer histologically proven', 'diagnosis of a detected anomaly', 'surveillance of a treated breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Oscar Lambret Center', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59100', 'city': 'Roubaix', 'country': 'France', 'facility': 'Centre Hospitalier - Pavillon Paul Gelé', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Clinique des Dentellières', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'overallOfficials': [{'name': 'Sophie TAIEB, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oscar Lambret Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}