NCT07291362

AI-Assisted Pathologist Performance Improvement: A Multicenter, Prospective, Randomized Controlled Trial

Artificial Intelligence Model-Assisted Improvement of Pathologists' Performance in Clinical Diagnostic Tasks: A Multicenter, Prospective, Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the added value of pathology-based AI models in the gastric cancer diagnostic workflow. The study will focus on comparing AI-assisted platform interpretation with conventional independent slide reading in terms of diagnostic accuracy (e.g., AUC), reading efficiency (e.g., comparison of time to diagnosis), quality of diagnostic reports, diagnostic confidence (Likert scale), and pathologists' satisfaction with the AI models. The investigators will also assess superiority for less-experienced (junior) pathologists and noninferiority for more-experienced (senior) pathologists. Successful completion of this project will provide high-level prospective evidence to support the standardized deployment, quality control, and broader application of pathology AI in the gastric cancer care pathway.

Conditions

• Pathology Foundation Model

Interventions

Type	Name	Description
OTHER	AI pathology model	Doctors in this group are required to use the AI pathology 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: 2025-11-01
• Primary completion: 2027-06-01
• Completion: 2027-11-01
• First posted: 2025-12-18
• Last updated: 2026-02-10

Locations

2 sites across 1 country: China