AIDOBE vs. 1.0

• Research type

  Research Study

• Full title

  Deployment and clinical evaluation of an AI-powered Digital Oncology Biomarker tool to guidE treatment in TNBC

• IRAS ID

  339044

• Contact name

  Navita Somaiah

• Contact email

  navita.somaiah@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Clinicaltrials.gov Identifier

  NCT06396754

• Clinicaltrials.gov Identifier

  ClinicalTrials.gov, NCT06396754

• Duration of Study in the UK

  1 years, 3 months, 31 days

• Research summary

  Tumour infiltrating lymphocytes (TILs) have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with triple negative breast cancer (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.
  

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  24/PR/0881

• Date of REC Opinion

  12 Aug 2024

• REC opinion

  Further Information Favourable Opinion