Viewing Study NCT07244094


Ignite Creation Date: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 1:38 AM
Study NCT ID: NCT07244094
Status: NOT_YET_RECRUITING
Last Update Posted: 2025-11-24
First Post: 2025-11-17
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: 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
Organization:

Study Overview

Official Title: A Study on Predicting the Risk of Distant Metastasis in Breast Cancer Using AI-Generated Spatial Pathological Maps
Status: NOT_YET_RECRUITING
Status Verified Date: 2025-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ARGUS project
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: