Pancreatic Cancer Screening Through The Detection Of Elastase-1 Combined With Other Examinations

Study Overview

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

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

DIAGNOSTIC_TEST: Pancreatic elastase-1 in blood serum

2023SDU-QILU-4

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-08-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-16
First Submitted that Met QC Criteria 2023-09-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-18
First Posted (ACTUAL) 2023-09-18	Results First Posted N/A	Last Verified 2024-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Patients with PDAC	DIAGNOSTIC_TEST: Pancreatic 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 signe
: Individuals at high risk for PDAC	DIAGNOSTIC_TEST: Pancreatic 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 signe
: Group of neuroendocrine neoplasm of pancreas	DIAGNOSTIC_TEST: Pancreatic 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 signe
: Group of solid pseudopapillary tumor of pancreas	DIAGNOSTIC_TEST: Pancreatic 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 signe
: Group of abnormally elevated CA19-9	DIAGNOSTIC_TEST: Pancreatic 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 signe
: Controls without pancreatic disease or elevated CA19-9	DIAGNOSTIC_TEST: Pancreatic 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 signe

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zhen Li, MD

Phone Number: 18560086106

Email: qilulizhen@sdu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Guangxi Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
LanZhou University

Investigators

PRINCIPAL_INVESTIGATOR: Ning Zhong, MD, Qilu Hospital of Shandong University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record