Clinical Trial

A Study on Predicting the Risk of Distant Metastasis in Breast Cancer Using AI-Generated Spatial Pathological Maps

Study acronym: ARGUS project
Recruiting
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Summary
The goal of this observational study is to develop and validate an artificial intelligence (AI) model for predicting the risk of distant metastasis in patients with primary breast cancer. The main question it aims to answer is: Can a multimodal AI model, trained on routinely available histopathological images, accurately predict the long-term risk of breast cancer metastasis? Researchers will analyze existing hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) stained tissue slides from patients who underwent surgery between 2015 and 2025. Clinical data will be used to train the AI model and evaluate its performance in predicting metastasis.
Protocol Amendment History 1 change
notable Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University -> Second Affiliated Hospital, Zhejiang University, School of Medicine 2026-08-09
Trial Details
NCT Number NCT07244094
Lead Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions Breast Cancer
Enrollment 400 participants
Start Date 2025-11-15
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-03-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-17