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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study aims to establish a diagnostic prediction model by using elastase 1, common clinical serological examinations, and imaging examinations including endoscopic ultrasonography (EUS), and to explore the diagnostic ability of the model in the high-risk population of PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum and pancreatic tissues to further improve the diagnostic performance of this model. In conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC, especially early resectable PDAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PDAC |
| ||
| Individuals at high risk for PDAC |
| ||
| Group of neuroendocrine neoplasm of pancreas |
| ||
| Group of solid pseudopapillary tumor of pancreas |
| ||
| Group of abnormally elevated CA19-9 |
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| Controls without pancreatic disease or elevated CA19-9 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic elastase-1 in blood serum | Diagnostic Test | Serum samples were collected from each patient to detect serum multiomics and pancreatic elastase-1 (PE-1). We examine multiomics in the pancreatic tissue collected from the patient who had undergone surgery or the necessary puncture examination and signed the informed consent form. |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) | The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) | The diagnostic value of diagnostic model versus EUS or other imaging examinations combined with diagnostic model in diagnosing PDAC. | 2 years |
| The content of elastase 1 |
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Inclusion Criteria:
Case groups (matching any of the following):
Control group:
(1) Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation.
Exclusion Criteria:
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Pancreatic cancer patients at high risk, patients with pancreatic cancer, benign pancreatic disease, borderline malignant disease, and abnormal elevation of CA199, as well as patients with other diseases without pancreatic disease are included. The Pancreatic cancer patients at high risk are those which are hereditary pancreatic cancer patients at high risk, chronic pancreatitis, new diabetes mellitus, or PCN pancreatic cystic tumor patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Li, MD | Contact | 18560086106 | qilulizhen@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ning Zhong, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ning Zhong | Recruiting | Jinan | Shandong | 250063 | China |
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| LanZhou University | OTHER |
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Serum and punctured tissue will be collected.
|
|
The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl) |
| 2 years |
| The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) | The ability of diagnostic models, multi-omics novel tumor markers, and common tumor markers to distinguish PDAC, benign pancreatic disease, borderline malignant disease, patients with abnormally elevated CA199, and controls without pancreatic disease. | 2 years |
| The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) | The diagnostic value of the diagnostic model, new tumor markers of multi-omics, and the common tumor markers to distinguish pancreatic tumors of different sites and sizes. | 2 years |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D007516 | Adenoma, Islet Cell |
| D010195 | Pancreatitis |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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