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AI Models in Clinical Pathology Diagnosis: A Multicenter RCT

NCT07408167 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2060

Last updated 2026-02-13

No results posted yet for this 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.

Conditions

  • Pathology Foundation Model

Interventions

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Li Liang · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07408167 on ClinicalTrials.gov