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Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
Sponsor: Institute of Cancer Research, United Kingdom
Summary
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. Furthermore, 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-08-01
Completion Date
2027-07-31
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
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.