AI Models in Clinical Pathology Diagnosis: A Multicenter RCT

Nanfang Hospital, Southern Medical University

Status: Not yet enrolling

Conditions: Pathology Foundation Model

Treatments: Other: AI model; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07408167

NFEC-2026-059

Details and patient eligibility

About

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.

Full description

In this study, investigators plan to enroll 60 pathologists with varying levels of experience and 2,000 patients requiring pathological diagnosis, with whole-slide images (WSIs) collected.

Enrollment: 2,060 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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2,060 participants in 2 patient groups, including a placebo group

AI-assisted group

Experimental group

Description:

Pathologists in this group are required to use the AI pathology diagnostic model to assist their diagnoses. The AI pathology model will provide a predicted result for each case.

Treatment:

Other: AI model

Independent Diagnosis Group (Control Group)

Placebo Comparator group

Description:

In this group, pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence.

Treatment:

Other: Control