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

NCT06396754 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Case45 Ltd

    collaborator UNKNOWN

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Navita Somaiah · Institute of Cancer Research, United Kingdom

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-31
Completion
2027-07-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06396754 on ClinicalTrials.gov