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Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer

NCT07541703 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2200

Last updated 2026-04-21

No results posted yet for this study

Summary

This retrospective observational study evaluates the prognostic performance of a locked Artificial Intelligence (AI)-based assay in patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative early breast cancer (EBC) from Austrian Breast \& Colorectal Cancer Study Group (ABCSG)-8, with extended follow-up from ABCSG-16 where available. ABCSG will provide digitized hematoxylin and eosin (H\&E) slides and required baseline clinicopathologic variables to Spotlight Medical without outcome data for blinded assay inference. ABCSG will then perform the prespecified statistical analyses linking assay outputs to clinical outcomes.

Conditions

  • Breast Cancer
  • Early Breast Cancer
  • ER-Positive HER2-Negative Breast Cancer

Interventions

DIAGNOSTIC_TEST

Locked AI-based prognostic assay

A locked AI-based assay applied to one digitized H\&E-stained surgical resection slide and routine baseline clinicopathologic variables to generate a continuous prognostic score and predefined risk categories.

Sponsors & Collaborators

  • Austrian Breast & Colorectal Cancer Study Group

    collaborator NETWORK

  • Spotlight Medical

    lead INDUSTRY

Principal Investigators

  • Michael Gnant, Univ.-Prof. Dr. · Medical University of Vienna

  • Martin Filipits, Assoc.Prof.Univ.-Doz.Mag.Dr. · Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

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 NCT07541703 on ClinicalTrials.gov