[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524600":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":13,"responsibleParty":36,"collaborators":38,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":7,"studyType":58,"phases":7,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":64,"whyStopped":7,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"The Leeds Teaching Hospitals NHS Trust","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","QPlasia OncoReader Breast (QPORB)","Automated diagnostic algorithm",[14],{"facility":15,"status":7,"city":16,"state":17,"zip":18,"country":19,"countryCode":20,"cosmosGeoPoint":21,"geoPoint":26,"contacts":27},"St James's University Hospital, Leeds Teaching Hospitals Trust","Leeds","West Yorkshire","LS97TF","United Kingdom","UK",{"type":22,"coordinates":23},"Point",[24,25],-1.54785,53.79648,{"lat":25,"lon":24},[28,33],{"name":29,"role":30,"phone":31,"phoneExt":7,"email":32},"Nicolas M Orsi, BSc MBChB PhD","CONTACT","+447903389824","n.m.orsi@leeds.ac.uk",{"name":34,"role":30,"phone":7,"phoneExt":7,"email":35},"Elizabeth M Walsh, BSc MBChB","e.m.walsh@leeds.ac.uk",{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[39,41],{"name":40,"class":6},"University of Leeds",{"name":42,"class":43},"4DPath","UNKNOWN","100524600","clinical-evaluation-of-a-computer-algorithm-to-report-breast-cancers-cleopatraa-100524600",false,"NCT06110845","CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers (CLEOPATRAA)","CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers","CLEOPATRAA","Inclusion Criteria:\n\n* all patients with a breast biopsy specimen processed at the pathology laboratory at SJUH, LTHT.\n\nExclusion Criteria:\n\n* Age \\\u003C16 or \\>110 years, non-carcinoma malignancies (e.g., sarcomas, malignant phyllodes tumours), carcinomas not arising from within the breast (e.g., cutaneous malignancies).","ALL","16 Years","110 Years",{"count":56,"type":57},800,"ESTIMATED","OBSERVATIONAL","The goal of this non-interventionist observational study is to test the performance of a computer algorithm (QPORB) which examines breast cancer biopsy digital images to provide diagnostic support. The main question\\[s\\] it aims to answer are:\n\n1. The principal research aim is to determine whether 4D Path's Technology Q-Plasia OncoReader Breast, that has been developed in the research setting, works robustly in the clinical environment (i.e. to define its real-life clinical utility) in terms of breast carcinoma grading and molecular subtyping\n2. The secondary research aim is to perform an economic analysis alongside the trial in order to establish the time, resource and cost savings that the technology could afford the NHS, the ideal price point for engaging with the technology and the cost:benefit ratio for evaluation by the National Institute for Clinical Excellence\n3. The tertiary research aim is to gather long-term follow-up data to better understand long-term response to therapy and prognosis and potential future uses of the algorithm\n\nParticipants's specimens will be tested alongside routine clinical workflows without intervention or consent. Researchers will compare the algorithm's results to those of routine diagnostic standard of care workflows.",[61],"Breast Cancer",[63],"Digital Pathology","NOT_YET_RECRUITING","2023-10-26",{"date":67,"type":68},"2023-11-01","ACTUAL",{"date":70,"type":57},"2023-12-01",{"date":72,"type":57},"2034-11-30",{"name":5,"class":6},1]