Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-21 @ 8:17 PM
Study NCT ID:
NCT04259866
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2020-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recall rate', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Screening']}, 'descriptionModule': {'briefSummary': 'To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images.\n\nThis study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female population candidated to breast cancer screening program', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer screening population\n\nExclusion Criteria:\n\n* previous cancer\n* breast prostheses'}, 'identificationModule': {'nctId': 'NCT04259866', 'briefTitle': 'FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS', 'organization': {'class': 'OTHER', 'fullName': '"G Criscuoli" Hospital'}, 'officialTitle': 'FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS: An Analysis of Findings Leading to Recall and Work-up in ASL Avellino Screening', 'orgStudyIdInfo': {'id': '05022020'}}, 'contactsLocationsModule': {'locations': [{'zip': '83100', 'city': 'Avellino', 'state': 'Av', 'country': 'Italy', 'facility': 'Graziella Di Grezia', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '"G Criscuoli" Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '1st level Assistant Physician', 'investigatorFullName': 'Graziella Di Grezia', 'investigatorAffiliation': 'Azienda Sanitaria ASL Avellino 2'}}}}