Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-28 @ 1:53 PM
Study NCT ID:
NCT05757232
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Construction of an Ultrasound Profile and a Mammographic Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study
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': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Tumors' characterization using descriptive criteria of the BI-RADS classification", 'timeFrame': '3 years', 'description': "The primary outcome will be tumors' characterization using descriptive criteria of the BI-RADS classification within the framework of a mammography and an ultrasound, and then the research of a correlation with the molecular profile in 203 patientes diagnosed with a breast cancer"}], 'secondaryOutcomes': [{'measure': 'Comparison of molecular profiles of breast cancers detected in the cohorte "mammography and ultrasound" with molecular profiles of breast cancers detected in the cohorte "tomosynthesis and ultrasound"', 'timeFrame': '3 years', 'description': 'Chi 2 test or Fisher test for molecular profiles in both cohorts'}, {'measure': 'Description of molecular profiles in breast cancers detected only with ultrasound', 'timeFrame': '3 years', 'description': 'Descriptive statistics concerning the selection of cancers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening campaign', 'molecular profile', 'tomosynthesis', 'ultrasound', 'mammography'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "PROFILS is a retrospective, exploratory study on data collected in 203 breast cancer cases diagnosed during a national screening campaign from 2015 to 2018.\n\nThe aim of the study is to analyse histological, clinical and radiological data collected during the screening campaign to build an ultrasound profile and a mammographic profile corresponding to brest cancers' different molecular sub-types (Luminal A, Luminal B, HER2+, Triple negative) using the BI-RADS classification.\n\nThe study has the following objectives:\n\n* To compare molecular profiles of breast cancers detected in a cohort of women diagnosed with tomosynthesis and ultrasound with molecular profiles of brest cancers detected in the cohort of women diagnosed with classical mammography and ultrasound\n* To describe molecular profiles of cancers detected only with ultrasound,"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The source data base of the study is from the Association Régionale des Dépistages Organisés des Cancers (ARDOC) 203 breast cancer cases have been selected in a cohort of 19 246 women who participated to the nationale breast cancer screening campaign', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women diagnosed with a breast cancer\n* Detection of a breast cancer during the screening campaign organized between june 2015 and july 2018 in the following geographic zones : Cantal, Haute Loire and Puys de Dôme\n\nExclusion Criteria:\n\n* Patients who expressed their opposition to the use of their personal data'}, 'identificationModule': {'nctId': 'NCT05757232', 'acronym': 'PROFILS', 'briefTitle': 'Construction of an Ultrasound Profile and a Mammographic Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Elsan'}, 'officialTitle': 'Construction of an Ultrasound Profile and a Mammography Profile Corresponding to the Different Molecular Subtypes of Brest Cancer. A Retrospective Study of 203 Cases Diagnosed During the National Screening Campaign in 2015-2018 (PROFILS)', 'orgStudyIdInfo': {'id': 'Etude PROFILS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancers cases diagnosed with tomosynthesis and ultrasound'}, {'label': 'Brest cancers cases diagnosed with mammography and ultrasound'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elsan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}