Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT04914494
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Predictive Score on Breast MRI
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': 'ESTIMATED', 'count': 428}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with MRI characteristics of breast lesions', 'timeFrame': '1 day', 'description': 'MRI characteristics of breast lesions :\n\nshape, contours, size, enhancement, perileeal edema, enhancement curve'}], 'secondaryOutcomes': [{'measure': 'predictive score for the benignity of lesions seen on MRI', 'timeFrame': '1 day', 'description': 'predictive score for the benignity of lesions seen on MRI (and not on mammography and ultrasound) with the criteria which will emerge after multivariate analysis and which will be weighted .\n\nscore out of 10, with 3 to 5 criteria rated from 0 to 2. 10 would be in favor of benignity and 0 in favor of malignancy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Women imaging', 'Diagnostic Imaging', 'Magnetic Resonance Imaging', 'Breast biopsy', 'Breast cancer detection', 'predictive factors', 'Radiology', 'Breast lesion diagnosis'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions.\n\nThe aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 18 to 50 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* women aged 18 and more\n* performed MRI-guided breast biopsy\n\nExclusion criteria:\n\n\\- Not MRI-guided breast biopsy'}, 'identificationModule': {'nctId': 'NCT04914494', 'briefTitle': 'Cancer Predictive Score on Breast MRI', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Malignity Predictive Factors on Breast MRI With Ultrasound and Mammography Occult Lesions', 'orgStudyIdInfo': {'id': 'RECHMPL21_0379'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Patrice TAOUREL, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}