AI Models in Clinical Pathology Diagnosis: A Multicenter RCT

NCT07408167 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Not applicable

Started

2026-03-01

Last updated

2026-02-13

Condition(s) studied

Pathology Foundation Model

Investigational drug(s) / intervention(s)

AI modelControl

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

Accepted

Pathologists: Inclusion Criteria: 1. Voluntarily provide written informed consent. 2. Age ≥ 20 years. 3. Have completed at least 1 year of training in pathological diagnosis. Exclusion Criteria: 1. Individuals with reading difficulties or a reading disorder. 2. Unwilling to participate in this study. Patients: Inclusion Criteria: 1. Voluntarily provide written informed consent. 2. Age ≥ 18 years. 3. Have available digital pathology images and relevant clinical information. Exclusion Criteria: 1. Missing data or data quality not meeting the requirements for analysis. 2. Deemed unsuitable for participation by the investigator. 3. Unwilling to participate in this study.

Primary outcome measure(s)

Area under ROC curve (AUC) — Assessments will be conducted within one week after the pathologists' diagnoses
Area under the curve

Trial sites (3)

Facility	City	Region
The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL	Chongqing	Chongqing Municipality
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07408167 on ClinicalTrials.gov ↗ ← All trials in China