AI Models Performance in Clinical Pathology Diagnostic Workflow
This study aims to evaluate the performance of AI models in the clinical pathology diagnostic workflow by measuring the area under the receiver operating characteristic curve (AUC).
AI model
+ Control
Other Study
Summary
Study start date: March 1, 2026
Actual date on which the first participant was enrolled.This study focuses on how well AI models perform in the clinical pathology diagnostic process. It involves 60 pathologists with different levels of experience and 2,000 patients who need a pathological diagnosis. The goal is to understand how AI can assist in analyzing whole-slide images, potentially improving the accuracy and efficiency of diagnosis. This is important because it could help address current challenges in pathology, such as high workload and complexity of cases. During the study, pathologists use AI models to help them analyze whole-slide images. The main outcome measured is the 'area under the ROC curve (AUC)', which is a measure of how well the AI models can distinguish between different diagnostic outcomes. This helps evaluate the performance of the AI models in assisting the pathologists.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2060 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL
Chongqing, ChinaOpen The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL in Google MapsNanfang Hospital, Southern Medical University
Guangzhou, ChinaThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, China