Triple Negative Breast Cancer
Conditions
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.
Interventions
OTHERAI-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.
Sponsors
Institute of Cancer Research, United Kingdom
Case45 Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
CONTACTLone Gothard
CONTACTRei Kow
PRINCIPAL_INVESTIGATORNavita Somaiah
Institute of Cancer Research, United Kingdom
Outcome results
None listed