Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-analysis on diagnostic and surgical specimens.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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.
Primary outcome measures
- To determine the reliability and performance of the process and AI tool [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06396754 · CCR6030