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| Name | Class |
|---|---|
| Qianfoshan Hospital | OTHER |
The investigators plan to develop a deep learning-based automatic interpretation model for Claudin18.2(CLDN18.2) using the institution's and multiple other centers' extensive pathological resources of digestive system adenocarcinomas. This study will not only strictly follow the latest domestic expert consensus and standards, but also aims to address current pain points in manual interpretation. It seeks to provide technical support for standardizing, objectifying, and streamlining CLDN18.2 testing, thereby advancing the application of precision medicine in the diagnosis and treatment of digestive system diseases. The project has clear clinical necessity and broad application prospects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective validation dataset | 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 October 1, 2025 at Nanfang Hospital, Southern Medical University (NFHSMU) | ||
| QFSH external validation dataset | 2000 slides from 1000 eligible individuals were obtained in the Qianfoshan Hospital (QFSH, Jinan, China) between January 2020 and February 2026, which was used to validate the model. | ||
| Randomized controlled trial | We conducted a randomized controlled trial(RCT)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 February 1, 2023 to establish the NFHSMU randomized controlled trial dataset. Following quality control, the slides were randomly allocated (1:1 ratio) into three groups: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 whole slide images(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 over 18 years with definitive pathological diagnoses.
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| Name | Affiliation | Role |
|---|---|---|
| Li Liang | Nanfang Hospital, Southern Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China | ||
| Qianfoshan Hospital |
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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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 |
| Jinan |
| Shandong |
| 250014 |
| China |