Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC

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.

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-analysis on diagnostic and surgical specimens

Other

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 outcomes

To determine the reliability and performance of the process and AI tool

Time frame: 6 months

Success rate of digitization of H&E slides & Turnaround time for biomarker report within standard patient pathways

Study contacts

Contact information is provided by the study sponsor or research team.

Lone Gothard

CONTACT

[email protected]

02086613460

Rei Kow

CONTACT

[email protected]

02034376805

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

Case45 Ltd

Registry information

Acronym: AIDOBE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 2, 2024
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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