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

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether measuring a digestive enzyme called elastase-1 in the blood, combined with other tests, can improve early detection of pancreatic cancer. **You may be eligible if...** - You have been diagnosed with pancreatic cancer (confirmed) - You are considered high risk for pancreatic cancer - You have been diagnosed with a pancreatic tumor such as a solid pseudopapillary tumor or pancreatic neuroendocrine tumor - You have another condition associated with elevated CA19-9 (a tumor marker in the blood) - You are being used as a healthy control and have no pancreatic disease **You may NOT be eligible if...** - You are under 18 years old - You have suspected but unconfirmed pancreatic disease - You have not provided informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.