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AI Models in Clinical Pathology Diagnosis: A Multicenter RCT
Sponsor: Nanfang Hospital, Southern Medical University
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.
Official title: Performance of AI Models in the Clinical Pathology Diagnostic Workflow: A Multicenter, Prospective, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
2060
Start Date
2026-03-01
Completion Date
2029-12-31
Last Updated
2026-02-13
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
Locations (3)
The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China