Trials / Not Yet Recruiting
Not Yet RecruitingNCT06396754
Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Institute of Cancer Research, United Kingdom · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-08-01
- Primary completion
- 2027-07-31
- Completion
- 2027-07-31
- First posted
- 2024-05-02
- Last updated
- 2026-03-27
Source: ClinicalTrials.gov record NCT06396754. Inclusion in this directory is not an endorsement.