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NCT07244094

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 95 Years

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2025-11-15

Completion Date

2027-03-07

Last Updated

2026-02-17

Healthy Volunteers

No

Conditions

Interventions

OTHER

Diagnostic Test: AI-Based Spatial Pathomic Analysis

This is an observational study with no therapeutic or procedural interventions. The "intervention" refers to the analytical method applied to existing data. Archived tissue samples (H\&E and IHC stained slides) will be digitally scanned and analyzed by a multimodal artificial intelligence (AI) model to develop a risk prediction tool for distant metastasis. Patients' clinical data will be collected for model training and validation. No direct interaction with patients occurs, and no treatment decisions are influenced by this study.

Locations (4)

Jilin Cancer Hospital

Changchun, Jilin, China

Cancer Institute and Hospital, Tianjin Medical University, China

Tianjin, Tianjin Municipality, China

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China