Prospective Pathology Foundation Models

Recruiting

• Conditions: Pancancer

• Registration Number: NCT07157618
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

Histopathology remains the gold standard for disease diagnosis, yet faces challenges including pathologist shortages and diagnostic model limitations. This underscores the critical need to develop deep learning-based pathology foundation models integrating prospective imaging and clinical data. Such models would enhance diagnostic accuracy and efficiency, enabling tumor grading, histo-molecular classification, and intelligent chemotherapy guidance - ultimately optimizing clinical workflows. However, a critical gap remains: the absence of prospectively validated, pan-disease pathology foundation models. Developing clinically validated models is therefore imperative.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-28
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2028-07
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Aged 18-75 years old.
2. Patients with complete pathological slides and clinical information.

Exclusion Criteria

1.Patients with missing data or specimens not meeting quality control requirements for analysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under ROC curve (AUC)	Diagnostic evaluation will be performed within 1 week when the WSIs are obtained	Area under the curve

Secondary Outcome Measures

Name	Time	Method
Sensitivity	Diagnostic evaluation will be performed within 1 week when the WSIs are obtained	The true positive rate (TPR) of the diagnostic platform, which is the ratio between the number of positive individuals correctly categorized by platform and the total number of actual positive individuals (%).
Specificity	Diagnostic evaluation will be performed within 1 week when the WSIs are obtained	The true negative rate (TNR) of the diagnostic platform, which is the ratio between the number of negative individuals correctly categorized by platform and the total number of actual negative individuals (%).

Trial Locations

Locations (2)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China