Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
Not yet recruiting
- Conditions
- Triple Negative Breast Cancer
- Registration Number
- NCT06396754
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Age ≥18 years
- Confirmed diagnosis of triple negative breast cancer (non-metastatic)
- Planned for neo-adjuvant systemic therapy
- Written consent to generic Tissue for Research donation
Exclusion Criteria
- Patients declined consent for generic Tissue for Research donation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the reliability and performance of the process and AI tool 6 months Success rate of digitization of H\&E slides \& Turnaround time for biomarker report within standard patient pathways
- Secondary Outcome Measures
Name Time Method