[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587001":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Catholic University of the Sacred Heart","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Integrated PRS-enhanced breast cancer risk assessment","EXPERIMENTAL","Women attending a Medical Genetics Clinic for breast cancer risk assessment, all undergoing CanRisk evaluation with and without PRS, without allocation to different interventions.",[13],"Genetic: Clinical pathway for breast cancer prevention based on PRS-integrated CanRisk assessment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"GENETIC","Clinical pathway for breast cancer prevention based on PRS-integrated CanRisk assessment","Standard genetic counseling followed by a blood draw (0.5 mL) for DNA extraction. The sample is processed using a high-throughput SNP genotyping platform, and the PRS, based on 313 SNPs, is calculated and integrated into the CanRisk model for refined breast cancer risk stratification. In conjunction with result disclosure, participants complete structured questionnaires to assess psychological impact and risk comprehension (questionnaire by Woof et al.). At the end of the study, both participants and healthcare professionals complete feasibility questionnaires to evaluate the implementation of the PRS-integrated clinical pathway (Care Process Self-Evaluation Tool, CPSET; Vanhaecht et al.).",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Stefania Boccia, Phd","Life Sciences and Public Health Department, Università Cattolica del Sacro Cuore, Rome, Italy","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Sara Farina, MD","CONTACT","0039 + 0630156808","sarafarins96@gmail.com",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Francesco A Causio, MD","francescoandrea.causio@unicatt.it",[36],{"facility":37,"status":38,"city":39,"state":20,"zip":20,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Policlinico Universitario Fondazione Agostino Gemelli","RECRUITING","Roma","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],11.10642,44.99364,{"lat":46,"lon":45},[49],{"name":28,"role":29,"phone":50,"phoneExt":20,"email":51},"063015","sara.farina@unicatt.it",{"type":25,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Stefania Boccia","Professor of Hygiene and Preventive Medicine","100587001","implementing-polygenic-risk-scores-for-breast-cancer-prevention-a-feasibility-study-100587001",false,"NCT06922708","Implementing Polygenic Risk Scores for Breast Cancer Prevention: a Feasibility Study","Implementing Polygenic Risk Scores for Breast Cancer Prevention: Protocol for a Feasibility Study in a Real-world Clinical Setting","MIG","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Voluntary consent to participate\n* Estimated risk of carrying an inherited pathogenic variant (in BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1) \\> 5%, (calculated on www.canrisk.org)\n* Healthy women with:\n\n  1. Known family history of breast cancer, or\n  2. Known familiarity with carriers of pathogenic variants for genes included in the CanRisk model (BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1), or\n  3. Known carriers of pathogenic variants for genes included in the CanRisk model (BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1)\n* Affected women with:\n\n  1. Diagnosis of unilateral breast cancer\n  2. Personal history of ovarian cancer\n\nExclusion Criteria:\n\n* Diagnosis or history of bilateral breast cancer\n* Diagnosis of ductal carcinoma in situ\n* Previous bilateral mastectomy\n* Life expectancy \\\u003C 12 months due to other medical conditions\n* Participation in interventional clinical trials for breast cancer prevention in the last 12 months\n* Carriers or relatives of carriers of pathogenic variants in genes not included in the CanRisk model (genes other than BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51D, RAD51C, BARD1)\n* Inability to provide informed consent",true,"FEMALE","18 Years","79 Years",{"count":68,"type":69},100,"ESTIMATED","INTERVENTIONAL",[72],"NA","This single-arm interventional feasibility study will evaluate whether integrating polygenic risk scores (PRS) into the CanRisk model can improve breast cancer risk prediction and personalized prevention in women at risk of breast cancer. The study will assess the organizational feasibility, patient acceptance, emotional impact and satisfaction of an integrated pathway combining PRS testing with standard genetic counseling and other risk factors at Fondazione Policlinico Universitario Agostino Gemelli IRCCS.",[75],"Breast Cancer",[77,78,79,80,81,82],"breast cancer","risk stratification","polygenic risk score","CanRisk model","feasibility study","personalized prevention","2026-07-31",{"date":85,"type":86},"2026-08-03","ACTUAL",{"date":88,"type":86},"2025-06-06",{"date":90,"type":69},"2026-11-30",{"name":5,"class":6},1]