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

NCT07291362 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-02-10

No results posted yet for this study

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

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.

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-06-30
Completion
2027-11-30

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 NCT07291362 on ClinicalTrials.gov