AI Models in Clinical Pathology Diagnosis: A Multicenter RCT

February 6, 2026 updated by: Nanfang Hospital, Southern Medical University

Performance of AI Models in the Clinical Pathology Diagnostic Workflow: A Multicenter, Prospective, Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

2060

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, China 510515
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Independent Diagnosis Group (Control Group)
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.
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.
Experimental: AI-assisted group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under ROC curve (AUC)
Time Frame: Assessments will be conducted within one week after the pathologists' diagnoses
Area under the curve
Assessments will be conducted within one week after the pathologists' diagnoses

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic time per case
Time Frame: Measured immediately after the pathologists' diagnosis
Time required for the pathologist to complete the diagnosis of each case in the AI-assisted diagnosis group compared with the independent diagnosis group. Diagnostic time is defined as the duration (in minutes/seconds) from initiating case review to finalizing and submitting the diagnostic report in the study system.
Measured immediately after the pathologists' diagnosis
Pathologists' diagnostic confidence
Time Frame: At the time of diagnosis for each case.
Self-reported diagnostic confidence of pathologists for each case in the AI-assisted diagnosis group compared with the independent diagnosis group. Diagnostic confidence will be rated by the reporting pathologist on a [10]-point Likert scale (e.g., 1 = very uncertain to 10 = very confident) immediately after completing the diagnosis. Higher scores indicate greater diagnostic confidence.
At the time of diagnosis for each case.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Investigators

  • Study Chair: Li Liang, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NFEC-2026-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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