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.
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.
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.
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.
Case-control
Prospective
Pancreatic elastase-1 in blood serum
Diagnostic testSerum 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.
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Treatment groupsSee each treatment group below.
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.
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.
The content of elastase 1
The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)
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.
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.
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Qilu Hospital of Shandong University
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
LanZhou University
Collaborator
