Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02698202
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Breast Cancer With Digital Breast Tomosynthesis
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'}]}, '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': 'RANDOMIZED', 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26877}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2016-02-26', 'studyFirstSubmitQcDate': '2016-02-26', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative incidence of T2+ cancers after screening', 'timeFrame': '2 years'}, {'measure': 'incidence of interval cancers', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Detection rate', 'timeFrame': '2 years'}, {'measure': 'recall rate', 'timeFrame': 'baseline'}, {'measure': 'Positive Predictive value', 'timeFrame': 'baseline'}, {'measure': 'diagnostic agreement between tomosynthesis and 2d mammography', 'timeFrame': 'baseline'}, {'measure': 'Detection rate of in situ ductal carcinoma', 'timeFrame': '2 years'}, {'measure': 'biopsy rate', 'timeFrame': 'baseline'}, {'measure': 'self-reported pain and discomfort during mammography', 'timeFrame': 'baseline'}, {'measure': 'x-ray dose', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tomosynthesis,sensitivity,specificity,screening,mammography'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '35103537', 'type': 'DERIVED', 'citation': 'Pattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266. doi: 10.1148/radiol.211132. Epub 2022 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.', 'detailedDescription': 'The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).\n\nWomen will be asked for informed consent when they attend the mammography. I they accept they will be randomised to one of the two arms.\n\nAll examinations will be read by two independent radiologists, in case of discordance a third reading is asked.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n45-70 years old women invited to breast cancer screening program who accepted to participate\n\nExclusion Criteria:\n\n* previous breast cancer diagnosis\n* pregnancy or suspicion of pregnancy\n* presence of BRCA1/2 gene mutation\n* Previous Digital Breast Tomosynthesis performed\n* unable to understand informed consent\n* chemotherapy in progress\n* presence of breast implant'}, 'identificationModule': {'nctId': 'NCT02698202', 'briefTitle': 'Screening for Breast Cancer With Digital Breast Tomosynthesis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group', 'orgStudyIdInfo': {'id': 'ReTomo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Breast Tomosynthesis', 'description': 'to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis', 'interventionNames': ['Device: Digital Breast Tomosynthesis']}, {'type': 'NO_INTERVENTION', 'label': 'standard mammography', 'description': 'to the control arm the usual 2D standard mammography exam will be offered'}], 'interventions': [{'name': 'Digital Breast Tomosynthesis', 'type': 'DEVICE', 'description': 'twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis', 'armGroupLabels': ['Digital Breast Tomosynthesis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Azienda Sanitaria Locale Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Pierpaolo Pattacini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inter-Institutional Imaging Department, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Regione Emilia-Romagna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}