Clinical Trial

AI Models in Clinical Pathology Diagnosis: A Multicenter RCT

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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.
Trial Details
NCT Number NCT07408167
Lead Sponsor Nanfang Hospital, Southern Medical University
Conditions Pathology Foundation Model
Enrollment 2,060 participants
Start Date 2026-03-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-13