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This project proposes to collect prospective multimodal data-such as pathology, imaging, and clinical information-and to perform integrative analyses. AI technologies can offer novel solutions for disease classification, tumor grading, histological subtyping, molecular subtyping, selection of chemotherapy regimens, risk stratification, treatment response prediction, report generation, and intelligent question-answering. This research provides important support for precision medicine and individualized treatment and has significant theoretical and practical implications. Conducting a prospective randomized controlled study better aligns with clinical application requirements and can accelerate the comprehensive deployment of AI systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZSCPH validation dataset | Approximately 1,000 prospective patients across various disease types will have digitized scanned images, imaging information, and clinicopathological data provided, collected from Zhongshan People's Hospital (Zhongshan, Guangdong, China) between October 2025 and September 2030. | ||
| NFHSMU validation dataset | We conducted a prospective validation study to compare the diagnostic performance among pathologists, our multimodal artificial intelligence model . This study was initiated on October 1, 2025 at Nanfang Hospital, Southern Medical University (NFHSMU). | ||
| Randomized controlled trial | We conducted a prospective randomized controlled trial to compare the diagnostic performance among pathologists, the multimodal artificial intelligence model, and pathologist-with-model-assisted diagnosis at Nanfang Hospital of Southern Medical University (NFHSMU).The trial commenced data collection on October 1, 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 or CT 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 or CT are obtained |
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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 with definitive pathological diagnoses. All cases were prospectively collected from Nanfang Hospital, Southern Medical University (NFHSMU) .
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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 | ||
| Zhongshan City People's 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)
| Sensitivity |
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 or CT are obtained |
| Zhongshan |
| Guangdong |
| 513000 |
| China |