[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407833":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":41,"locations":50,"responsibleParty":100,"collaborators":12,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":12,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":53,"whyStopped":12,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"1-year screening interval","NO_INTERVENTION","Women will follow the normal screening program (they will be invited to screen every year)",null,{"label":14,"type":15,"description":16,"interventionNames":17},"2-year screening interval","EXPERIMENTAL","Women will be invited to screen every two years",[18],"Diagnostic Test: screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice",{"label":20,"type":15,"description":21,"interventionNames":22},"3-tailored screening interval","the screening interval will be decided on the basis of breast density. Women with very dense breast (BI-RADS category D) will be referred to 1-year interval whereas women with less dense breast to 2-year interval (BI-RADS category A, B, C)",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DIAGNOSTIC_TEST","screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice","women will be screened for breast cancer using tomosynthesis and synthetic 2D mammography with an interval defined according to their randomization arm for a follow-up period of 6 years;",[14,20],[30,34,38],{"name":31,"affiliation":32,"role":33},"Fabio Falcini, MD","IRST IRCCS","STUDY_CHAIR",{"name":35,"affiliation":36,"role":37},"Livia Giordano, MD","A.O.U. Città della Salute e della Scienza","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Marco Zappa, MD","ISPRO Firenze",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":12,"email":46},"Oriana Nanni","CONTACT","+39 0543 739100","oriana.nanni@irst.emr.it",{"name":48,"role":44,"phone":12,"phoneExt":12,"email":49},"Chiara Zingaretti","cc.ubsc@irst.emr.it",[51,67,80,90],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Irst Irccs","RECRUITING","Meldola (FC)","FC","47014","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],12.0626,44.12775,{"lat":63,"lon":62},[66],{"name":31,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":68,"status":69,"city":70,"state":12,"zip":12,"country":57,"countryCode":58,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Istituto per lo studio, la prevenzione e la rete oncologica (ISPRO)","NOT_YET_RECRUITING","Florence",{"type":60,"coordinates":72},[73,74],11.24626,43.77925,{"lat":74,"lon":73},[77,78],{"name":39,"role":44,"phone":12,"phoneExt":12,"email":12},{"name":79,"role":44,"phone":12,"phoneExt":12,"email":12},"Paola Mantellini, MD",{"facility":81,"status":53,"city":82,"state":12,"zip":12,"country":57,"countryCode":58,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"AUSL Romagna","Forlì",{"type":60,"coordinates":84},[85,86],12.04144,44.22177,{"lat":86,"lon":85},[89],{"name":31,"role":44,"phone":12,"phoneExt":12,"email":12},{"facility":91,"status":69,"city":92,"state":12,"zip":12,"country":57,"countryCode":58,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"AOU Città della Salute e della Scienza","Torino",{"type":60,"coordinates":94},[95,96],11.99138,44.88856,{"lat":96,"lon":95},[99],{"name":35,"role":44,"phone":12,"phoneExt":12,"email":12},{"type":101,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100407833","what-is-the-best-interval-to-screen-women-45-49-and-70-74-for-breast-cancer-100407833",false,"NCT04590560","What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?","What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer","MISS","Inclusion Criteria:\n\n1. Women invited for their first or second mammography (45 or 46 y\u002Fo) presenting for screening;\n2. Willingness and ability to comply with scheduled visits;\n3. Written informed consent obtained prior to performing any protocol-related procedures.\n\nExclusion Criteria:\n\n1. Pregnancy status;\n2. Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis;\n3. Ascertained heredo-familial risk according to the standard family history used in screening programs;\n4. Participation in another clinical trial on BC screening;\n5. Inability to provide signed informed consent.","FEMALE","45 Years","49 Years",{"count":114,"type":115},60000,"ESTIMATED","INTERVENTIONAL",[118],"NA","Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.",[121],"Breast Cancer",[123],"Breast cancer, screening, diagnosis, mammography","2024-12-04",{"date":126,"type":127},"2024-12-09","ACTUAL",{"date":129,"type":127},"2020-02-06",{"date":131,"type":115},"2026-02",{"name":5,"class":6},4]