NCT07408167

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,060

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Dec 2029

First Submitted

Initial submission to the registry

February 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

February 6, 2026

Last Update Submit

February 6, 2026

Conditions

Pathology Foundation Model

Keywords

Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Area under ROC curve (AUC)

    Area under the curve

    Assessments will be conducted within one week after the pathologists' diagnoses

Secondary Outcomes (2)

  • Diagnostic time per case

    Measured immediately after the pathologists' diagnosis

  • Pathologists' diagnostic confidence

    At the time of diagnosis for each case.

Study Arms (2)

AI-assisted group

EXPERIMENTAL

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

Independent Diagnosis Group (Control Group)

PLACEBO COMPARATOR

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

Interventions

AI modelOTHER

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.

AI-assisted group
ControlOTHER

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

Independent Diagnosis Group (Control Group)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily provide written informed consent.
  • Age ≥ 20 years.
  • Have completed at least 1 year of training in pathological diagnosis.

You may not qualify if:

  • Individuals with reading difficulties or a reading disorder.
  • Unwilling to participate in this study.
  • Patients:
  • Voluntarily provide written informed consent.
  • Age ≥ 18 years.
  • Have available digital pathology images and relevant clinical information.
  • Missing data or data quality not meeting the requirements for analysis.
  • Deemed unsuitable for participation by the investigator.
  • Unwilling to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL

Chongqing, Chongqing Municipality, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China 510515, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Study Officials

  • Li Liang

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Central Study Contacts

Zhengyu Zhang

CONTACT

13837365993zzyusmu@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 13, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)