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

Enrolling by invitation · Not applicable

Conditions studied: Pathology Foundation Model

In brief

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.

Key facts

Study ID: NCT07291362
Run by: Nanfang Hospital, Southern Medical University
People needed: 1000
Starts: 2025-11-01
Expected to finish: 2027-11-01
Last updated by the study team: 2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Sex: ≥ 18 years of age;
Patients undergoing gastric mucosal biopsy or gastric cancer surgical resection, with available digital pathology images and clinical information.

You may not qualify if…

Missing data or data of insufficient quality for analysis

Where it is running

Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China

Full record on ClinicalTrials.gov

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