[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498381":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":17,"locations":22,"responsibleParty":38,"collaborators":7,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":7,"maxAge":7,"enrollmentInfo":50,"targetDuration":7,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":7,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","Germinal BRCA","We will conduct a multicenter prospective observational study aimed at automatically implementing the predictive model and collecting US images of healthy ovaries from patients tested for germline BRCA pathogenetic variants according to current indications.",[14],{"name":15,"affiliation":5,"role":16},"Camilla Nero","PRINCIPAL_INVESTIGATOR",[18],{"name":15,"role":19,"phone":20,"phoneExt":7,"email":21},"CONTACT","+390630156779","camilla.nero@policlinicogemelli.it",[23],{"facility":5,"status":24,"city":25,"state":7,"zip":7,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"RECRUITING","Rome","Italy","IT",{"type":29,"coordinates":30},"Point",[31,32],12.51133,41.89193,{"lat":32,"lon":31},[35],{"name":36,"role":19,"phone":37,"phoneExt":7,"email":21},"Camilla Nero, PhD","0630158667",{"type":39,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100498381","prediction-of-germline-brca-12-genes-from-healthy-ovaries-100498381",false,"NCT05769517","Prediction of Germline BRCA 1\u002F2 Genes From Healthy Ovaries","Prediction of Germline BRCA 1\u002F2 Genes Pathogenetic Variants From Healthy Ovaries Ultrasound Images: Radiogenomics as an Innovative Tool to Prevent BRCA-related Cancers","PROBE-II","Inclusion Criteria:\n\nAvailability of gBRCA1\u002F2 test results\n\nTransvaginal pelvic US performed providing at least one picture of one healthy ovary\n\nUS images stored in .dicom format.\n\nExclusion Criteria:\n\nPersonal diagnosis of OC\n\nOvarian abnormal findings (eg. ovarian endometriomas, dermoid cyst, ovarian cystoadenofibroma, ovarian borderline tumour…) with the exception of functional cysts at pelvic US\n\ngBRCA1\u002F2 testing results nor provided by an ISO 1589 accredited laboratory\n\nRefusal to provide written informed consent",true,"FEMALE",{"count":51,"type":52},6465,"ESTIMATED","OBSERVATIONAL","The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and\u002For 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases:\n\nModel development phase (ambispective)\n\nAIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis;\n\nImplementation and validation phase (prospective)\n\nAIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.",[56,57,58],"BRCA Mutation","Ovarian Cancer","Ultrasound Therapy; Complications","2026-04-21",{"date":61,"type":62},"2026-04-24","ACTUAL",{"date":64,"type":62},"2023-03-20",{"date":66,"type":52},"2031-03-08",{"name":5,"class":6},1]