[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546577":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":16,"locations":7,"responsibleParty":26,"collaborators":28,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":7,"enrollmentInfo":41,"targetDuration":7,"studyType":44,"phases":7,"briefSummary":45,"conditions":46,"keywords":7,"overallStatus":48,"whyStopped":7,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":7},{"fullName":5,"class":6},"Institute of Cancer Research, United Kingdom","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"AI-analysis on diagnostic and surgical specimens","The analysis will report a list of AI-based biomarkers to assess the tumour-immune spatial microenvironment as well as final spatial immune-ecology prognostic (SIPA) reports for every patient.",[13],{"name":14,"affiliation":5,"role":15},"Navita Somaiah","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Rei Kow","CONTACT","02034376805","rei.kow@icr.ac.uk",{"name":23,"role":19,"phone":24,"phoneExt":7,"email":25},"Lone Gothard","02086613460","lone.gothard@icr.ac.uk",{"type":27,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[29],{"name":30,"class":31},"Case45 Ltd","UNKNOWN","100546577","deployment-and-clinical-evaluation-of-an-ai-powered-digital-oncology-biomarker-tool-to-guide-treatment-in-tnbc-100546577",false,"NCT06396754","Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC","AIDOBE","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis of triple negative breast cancer (non-metastatic)\n* Planned for neo-adjuvant systemic therapy\n* Written consent to generic Tissue for Research donation\n\nExclusion Criteria:\n\n* Patients declined consent for generic Tissue for Research donation","ALL","18 Years",{"count":42,"type":43},50,"ESTIMATED","OBSERVATIONAL","TILs have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with TNBC in multiple studies (Level-1B evidence for clinical validity as per REMARK criteria). TNBC patients with excellent survival outcome and low incidence of metastasis can be identified using a manual TIL score.\n\nFurthermore, a fully end-to-end blinded evaluation of the same algorithm to be used in this study achieved \\>90% accuracy for predicting disease free survival (DFS) and overall survival (OS) in the pooled analysis of seven adjuvant phase-III TNBC trials.",[47],"Triple Negative Breast Cancer","NOT_YET_RECRUITING","2026-03-23",{"date":51,"type":52},"2026-03-27","ACTUAL",{"date":54,"type":43},"2026-08-01",{"date":56,"type":43},"2027-07-31",{"name":5,"class":6}]