Actively Recruiting
A Study on Predicting the Risk of Distant Metastasis in Breast Cancer Using AI-Generated Spatial Pathological Maps
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-02-17
400
Participants Needed
4
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on Predicting the Risk of Distant Metastasis in Breast Cancer Using AI-Generated Spatial Pathological Maps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically confirmed primary invasive breast carcinoma
- Underwent curative surgical resection (mastectomy or breast-conserving surgery) between January 2015 and December 2025
- Retention of the primary tumor specimen before starting neoadjuvant therapy
- Availability of high-quality, digitizable Hematoxylin and Eosin (H&E) stained whole-slide images
- Availability of consecutive tissue sections from the same tumor block for multiplex immunohistochemistry staining
- Complete clinicopathological data and follow-up information including TNM stage, histological grade, molecular subtype, adjuvant treatment records, and distant metastasis-free survival data
- Minimum follow-up of 5 years with detailed distant metastasis event information
You will not qualify if you...
- Pure ductal carcinoma in situ (DCIS) without an invasive component
- Special histological subtypes of invasive carcinoma with distinct biological behaviors (e.g., metaplastic carcinoma)
- No original lesion samples retained before neoadjuvant therapy
- Presence of contralateral breast cancer or history of any other prior malignancy except cured non-melanoma skin cancer or carcinoma in situ of the cervix
- H&E or IHC slides with significant technical artifacts preventing reliable image analysis
- Low tumor cellularity (tumor area less than 10% in scanned field)
- Unavailable or unalignable consecutive tissue sections preventing spatial registration of images
- Lack of essential clinicopathological or follow-up data needed for model training or validation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
2
Cancer Institute and Hospital, Tianjin Medical University, China
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
3
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Actively Recruiting
4
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
J
Jiaojiao Zhou
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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