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NCT06396754Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
30 Apr 2024
Start date
1 Aug 2026
Primary completion date
31 Jul 2027
Lead sponsor
Institute of Cancer Research, United Kingdom
NCT number
NCT06396754

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 1 Aug 2026 to the primary completion date, 31 Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients declined consent for generic Tissue for Research donation

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.