ClinicalTrials.gg
Not yet recruitingNCT06396754AIDOBEUpdated Nov 4, 2026

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

An observational study in Triple Negative Breast Cancer, sponsored by Institute of Cancer Research, United Kingdom. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Institute of Cancer Research, United Kingdom · Observational

Updated Nov 4, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Triple Negative Breast Cancer
03

In context

Triple Negative Breast Neoplasms

1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.

This study's planned enrollment of 50 is below the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

Institute of Cancer Research, United Kingdom is the lead sponsor of 113 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with triple negative breast cancer requiring neoadjuvant systemic therapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Confirmed diagnosis of triple negative breast cancer (non-)
  • Planned for systemic therapy
  • Written consent to generic Tissue for Research donation

Exclusion criteria

Exclusion Criteria:

  • Patients declined consent for generic Tissue for Research donation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • OtherAI-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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Dec 2026; primary completion for Nov 2027, 11 months later.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Aug 2026 → Dec 2026, primary completion Jul 2027 → Nov 2027 and completion Jul 2027 → Nov 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2024
First posted
May 2, 2024
StartEst.
Dec 1, 2026was Aug 2026
Primary completionEst.
Nov 30, 2027was Jul 2027
CompletionEst.
Nov 30, 2027was Jul 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 1, 2026→Dec 1, 2026
Nov 4, 2026
Primary completion
Jul 31, 2027→Nov 30, 2027
Nov 4, 2026
Study completion
Jul 31, 2027→Nov 30, 2027
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Start date Aug 1, 2026→Dec 1, 2026
    Primary completion Jul 31, 2027→Nov 30, 2027
    Study completion Jul 31, 2027→Nov 30, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06396754
Collaborators
Case45 Ltd
Responsible party
Sponsor
First posted
May 2, 2024
Start date
Dec 1, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Rei Kow
Contact
rei.kow@icr.ac.uk
02034376805
Lone Gothard
Contact
lone.gothard@icr.ac.uk
02086613460
Navita Somaiah
principal investigator · Institute of Cancer Research, United Kingdom

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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