RecruitingNCT06041009

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

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

Sponsor

Qilu Hospital of Shandong University

Enrollment

2,100 participants

Start Date

May 5, 2023

Study Type

OBSERVATIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria3

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.

Interventions

DIAGNOSTIC_TESTPancreatic elastase-1 in blood serum

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.