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The research objective of this project is to conduct a large-scale and prospective real-world validation of the Pancreatic Cancer Screening Model PANDA, which was developed based on deep learning and plain CT scans in previous studies. This validation will be carried out across different scenarios at the First Affiliated Hospital of Zhejiang University, leveraging clinical big data. The goal is to verify the model's role in suggesting and supplementing the diagnosis of PDAC in clinical practice, thereby laying the groundwork for large-scale opportunistic screening of PDAC.
This study focuses on potential cases of clinically missed PDAC. It aims to evaluate the pancreatic cancer screening model PANDA, based on deep learning and non-enhanced CT scans, in a prospective real-world cohort from multiple clinical scenarios at the First Affiliated Hospital of Zhejiang University. The study will track patients with negative imaging reports but positive PANDA model findings, verifying their pathology through gold standard examinations to assess PANDA's efficacy. It aims to validate the model's utility, applicability, sensitivity, and specificity.
Based on these objectives, the study will undertake the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDAC | Experimental | According to the PANDA output results, those with the highest probability of PDAC among nonPDAC, PDAC, and normal categories are categorized into the PDAC group. |
|
| nonPDAC | No Intervention | According to the PANDA output results, those with the highest probability of nonPDAC among nonPDAC, PDAC, and normal categories are categorized into the nonPDAC group. | |
| Normal | No Intervention | According to the PANDA output results, those with the highest probability of Normal among nonPDAC, PDAC, and normal categories are categorized into the Normal group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy or operation | Diagnostic Test | To obtain a biopsy pathology or surgical pathology according to the clinical process of PDAC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | From diagnosis of PDAC to 3 years later |
| Measure | Description | Time Frame |
|---|---|---|
| TNM stage | Staging of pancreatic cancer | 1 day (evaluate through CT imaging before surgery) |
| Resectability grading | Resectability grading of pancreatic cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Zhang, Associate professor | Contact | 13819137113 | qi.zhang@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China | ||
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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The study divides enrolled patients into three groups based on PANDA's output results: nonPDAC, PDAC, and normal.
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| 1 day (evaluate through CT imaging before surgery) |
| Tumor markers | Characteristic presence in malignant tumor cells or substances produced abnormally by malignant tumor cells,like CA199 | Immediately after recall |
| the First Affiliated Hospital, School of Medicine, Zhejiang University |
| Hangzhou |
| Zhejiang |
| 310009 |
| China |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |