[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624889":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":18,"locations":24,"responsibleParty":47,"collaborators":10,"id":49,"slug":10,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Azienda Sanitaria Locale CN2 Alba-Bra","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Screening cohort",null,"Women aged 45-75 who underwent routine mammographic screening within the \"Prevenzione Serena\" program at ASL CN2 between September 2023 and May 2024. Breast density (BI-RADS A-D) will be evaluated, along with recall rates, false-positive findings, and comparisons of automated breast-density assessment (Insight BD) with radiologist readings. No interventions are administered; data are collected retrospectively from clinical records.",[13],"Other: No intervention is administered.",[15],{"type":6,"name":16,"description":16,"armGroupLabels":17,"otherNames":10},"No intervention is administered.",[9],[19],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Francesco Lucio, Principal Investigator","CONTACT","+39.0172.1408486","flucio@aslcn2.it",[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"SSD Fisica Sanitaria - Ospedale Michele e Pietro Ferrero di Verduno (CN) - ASL CN2","RECRUITING","Verduno","Italy\u002FCN","12060","Italy",{"type":33,"coordinates":34},"Point",[35,36],7.93074,44.66614,{"lat":36,"lon":35},[39,40,43,45],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},{"name":41,"role":42,"phone":10,"phoneExt":10,"email":10},"Anna Sardo","SUB_INVESTIGATOR",{"name":44,"role":42,"phone":10,"phoneExt":10,"email":10},"Michele Lo Bello",{"name":46,"role":42,"phone":10,"phoneExt":10,"email":10},"Francesco Testa",{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100624889",false,"NCT07415499","Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis","Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis","SINATRA","Inclusion Criteria:\n\n* Women aged 45 to 75 years who participated in the \"Prevenzione Serena\" mammography screening program and underwent screening mammography at ASL CN2 between September 25, 2023, and May 3, 2024.\n* Signed informed consent or equivalent substitute declaration, when applicable.\n\nExclusion Criteria:\n\n* Women with a history of mastectomy.\n* Women with breast implants.\n* Women with cardiac implantable devices, such as pacemakers or loop recorders.\n* Cases in which the Insight BD software cannot be applied due to compression thickness below 15 mm.","FEMALE","45 Years","75 Years",{"count":60,"type":61},3300,"ESTIMATED","OBSERVATIONAL","This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program \"Prevenzione Serena\".\n\nBreast density is an important factor because dense breast tissue can make it more difficult to detect breast cancer on a mammogram. Dense tissue and tumors both appear white on a mammogram, which may hide abnormalities and lead to missed cancers or false-positive results.\n\nWomen aged 45 to 75 years who underwent routine mammographic screening at ASL CN2 between September 2023 and May 2024 will be included. Breast density will be classified using the BI-RADS system (categories A-D), and the study will assess whether women with dense breasts (categories C and D) experience higher rates of recalls for second-level examinations such as ultrasound, MRI, etc).\n\nThe study also includes an internal validation of Insight BD, an automated breast-density measurement software used at ASL CN2. The software will be evaluated using a mammography phantom (to verify technical accuracy) and by comparing its BI-RADS density classifications with readings from two radiologists (one expert and one less experienced). This will help determine whether the software can support radiologists, especially in evaluating dense breast tissue.\n\nAdditional factors such as menopausal status, family history of breast cancer, and hormone therapy will also be examined to understand how they relate to breast density and screening outcomes. The study aims to quantify the frequency of false-positive recalls-cases in which additional tests are recommended but cancer is not found-because these events can increase patient anxiety and healthcare workload.\n\nUltimately, this research seeks to provide evidence that may inform future screening guidelines and support more personalized approaches, particularly for women with dense breasts.",[65,66],"Breast Cancer Screening","Breast Cancer Screening and Diagnosis",[68,69,70,71,72,73],"Breast cancer","Breast cancer screening","BRADS","Mammography","Dense breast","Breast imaging","2026-02-16",{"date":76,"type":77},"2026-02-17","ACTUAL",{"date":79,"type":77},"2026-01-12",{"date":81,"type":61},"2026-09",{"name":5,"class":6},1]