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| Name | Class |
|---|---|
| Qianfoshan Hospital | OTHER |
| Zhejiang University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| First Affiliated Hospital of Shantou University Medical College |
Histopathology remains the gold standard for disease diagnosis, yet faces challenges including pathologist shortages and diagnostic model limitations. This underscores the critical need to develop deep learning-based pathology foundation models integrating prospective imaging and clinical data. Such models would enhance diagnostic accuracy and efficiency, enabling tumor grading, histo-molecular classification, and intelligent chemotherapy guidance - ultimately optimizing clinical workflows. However, a critical gap remains: the absence of prospectively validated, pan-disease pathology foundation models. Developing clinically validated models is therefore imperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QFSH external validation dataset | 1000 slides from 1000 eligible individuals were obtained in the Qianfoshan Hospital (QFSH, Jinan, China) between January 2020 and July 2025, which was used to validate the pathology foundation models. | ||
| Prospective validation datasets | We conducted a prospective validation study to compare the diagnostic performance among pathologists, our pathology foundation model, and pathologist-with-AI-assisted diagnosis. This study was initiated on August 28, 2025 at Nanfang Hospital, Southern Medical University, The First Affiliated Hospital, Zhejiang University School of Medicine, The First Affiliated Hospital of Zhengzhou University, Zhujiang Hospital, Southern Medical University, Zhongshan People's Hospital, The First Affiliated Hospital of Shantou University Medical College, and Xijing Hospital, Fourth Military Medical University. | ||
| Randomized controlled trial | We conducted a prospective randomized controlled trial to compare the diagnostic performance among pathologists, the pathology foundation model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on August 28, 2025 to establish the NFHSMU randomized controlled trial dataset. Following quality control, the slides were randomly allocated (1:1:1 ratio) into three groups:Model-only group/Pathologist-only group/Model-assisted pathologist group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under ROC curve (AUC) | Area under the curve | Diagnostic evaluation will be performed within 1 week when the WSIs are obtained |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The true negative rate (TNR) of the diagnostic platform, which is the ratio between the number of negative individuals correctly categorized by platform and the total number of actual negative individuals (%). | Diagnostic evaluation will be performed within 1 week when the WSIs are obtained |
| Sensitivity |
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Inclusion Criteria:
Exclusion Criteria:
1.Patients with missing data or specimens not meeting quality control requirements for analysis.
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Inclusion criteria comprised patients aged 18-75 years with definitive pathological diagnoses. All cases were prospectively collected from Nanfang Hospital, Southern Medical University (NFHSMU) .
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengyu Zhang | Contact | +8613837365993 | zzyusmu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Liang | Nanfang Hospital, Southern Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
Requests for the data collected and analyzed in this study will be considered if the application is in line with public benefits and the applicant is willing to sign a data access agreement. Contact can be through the corresponding author.
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| OTHER |
| Zhujiang Hospital | OTHER |
| Air Force Military Medical University, China | OTHER |
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Samples Without DNA: Samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)
The true positive rate (TPR) of the diagnostic platform, which is the ratio between the number of positive individuals correctly categorized by platform and the total number of actual positive individuals (%). |
| Diagnostic evaluation will be performed within 1 week when the WSIs are obtained |
| Qianfoshan Hospital | Recruiting | Jinan | Shandong | 250014 | China |
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