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NCT06396754 Clinical Trial

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

Triple Negative Breast Cancer Clinical Trial

— AIDOBE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06396754
Other study ID # CCR6030
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date October 31, 2025

Study information
Verified date April 2024
Source Institute of Cancer Research, United Kingdom
Contact Rei Kow
Phone 02034376805
Email rei.kow@icr.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Institute of Cancer Research, United Kingdom Case45 Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the reliability and performance of the process and AI tool Success rate of digitization of H&E slides & Turnaround time for biomarker report within standard patient pathways 6 months
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