Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations

Study Overview
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Brief Summary
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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.

Official Title
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Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.

Conditions
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Pancreatic Ductal Adenocarcinoma, Pancreatic Diseases, Pancreatic Elastase 1, Pancreatic Neuroendocrine Tumor, Pancreatitis, Pancreatic Neoplasms

Intervention / Treatment
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* Diagnostic Test: Pancreatic elastase-1 in blood serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case groups (matching any of the following): Patients with pancreatic cancer with recognized diagnostic criteria or conclusions. Patients who are the high-risk group of pancreatic cancer. Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions. Patients with other diseases with abnormally elevated CA19-9. Control group: (1) Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation. Exclusion Criteria: Patients who are younger than 18 years of age. Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis. Patients who have not signed informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with PDAC<br> | Diagnostic Test: Pancreatic elastase-1 in blood serum<br>* 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.<br>* Other names: Multiomics in blood serum or tissue;|
| Individuals at high risk for PDAC<br> | Diagnostic Test: Pancreatic elastase-1 in blood serum<br>* 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.<br>* Other names: Multiomics in blood serum or tissue;|
| Group of neuroendocrine neoplasm of pancreas<br> | Diagnostic Test: Pancreatic elastase-1 in blood serum<br>* 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.<br>* Other names: Multiomics in blood serum or tissue;|
| Group of solid pseudopapillary tumor of pancreas<br> | Diagnostic Test: Pancreatic elastase-1 in blood serum<br>* 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.<br>* Other names: Multiomics in blood serum or tissue;|
| Group of abnormally elevated CA19-9<br> | Diagnostic Test: Pancreatic elastase-1 in blood serum<br>* 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.<br>* Other names: Multiomics in blood serum or tissue;|
| Controls without pancreatic disease or elevated CA19-9<br> | Diagnostic Test: Pancreatic elastase-1 in blood serum<br>* 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.<br>* Other names: Multiomics in blood serum or tissue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |