NCT07408167

AI Models in Clinical Pathology Diagnosis: A Multicenter RCT

Performance of AI Models in the Clinical Pathology Diagnostic Workflow: A Multicenter, Prospective, Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,060 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the incremental value of pathology-based artificial intelligence (AI) models in a pan-disease diagnostic workflow. The study will primarily compare interpretation using an AI-assisted platform with conventional independent slide reading in terms of diagnostic accuracy (e.g., AUC), reading efficiency (e.g., diagnostic time), diagnostic report quality, diagnostic confidence (Likert scale), and pathologists' satisfaction with the AI model. Investigators will also assess superiority among less experienced (junior) pathologists and non-inferiority among more experienced (senior) pathologists. Successful completion of this project will provide high-level prospective evidence to support standardized deployment, quality control, and broader implementation of pathology AI in clinical practice. This trial may also evaluate the potential benefits and risks of using AI tools in medical research.

Detailed description

In this study, investigators plan to enroll 60 pathologists with varying levels of experience and 2,000 patients requiring pathological diagnosis, with whole-slide images (WSIs) collected.

Conditions

• Pathology Foundation Model

Interventions

Type	Name	Description
OTHER	AI model	Doctors in this group are required to use the AI model to assist their diagnoses. The AI pathology model will provide a predicted result for each case.
OTHER	Control	Pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

3 sites across 1 country: China