RecruitingNCT07244094

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

Enrollment

400 participants

Start Date

Nov 15, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study uses AI to analyze detailed tissue slide images from breast cancer surgeries to predict which patients are at higher risk of the cancer spreading to distant organs. The goal is to create a tool that helps doctors plan more personalized follow-up care without needing additional tests. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with invasive breast cancer confirmed by biopsy - You had surgery (mastectomy or lumpectomy) between January 2015 and December 2025 - Tissue samples and clinical data from your surgery are available **You may NOT be eligible if...** - You had a second primary breast cancer (not a recurrence) - Your tissue samples or medical records are unavailable or incomplete - You received neoadjuvant therapy before surgery and no pre-treatment samples exist Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiagnostic 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.