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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms; Pancreatic Diseases; Pancreatitis; Pancreatic Ductal Adenocarcinoma; Pancreatic Neuroendocrine Tumor; Pancreatic Elastase 1
• Intervention / Treatment: Diagnostic test: Pancreatic elastase-1 in blood serum

• Study Type: Observational
• Enrollment (Estimated): 2100

Contacts and Locations

• Study Contact: Name: Zhen Li, MD; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250063
      • Recruiting
      • Ning Zhong
      • Contact: Zhen Li, MD; Phone Number: 18560086106; Email: qilulizhen@sdu.edu.cn
      • Contact: Ning Zhong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

Case groups (matching any of the following):

1. Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.
2. Patients who are the high-risk group of pancreatic cancer.
3. Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions.
4. 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:

1. Patients who are younger than 18 years of age.
2. Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis.
3. Patients who have not signed informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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 signed the informed consent form.; Other Names: Multiomics in blood serum or tissue
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 signed the informed consent form.; Other Names: Multiomics in blood serum or tissue
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 signed the informed consent form.; Other Names: Multiomics in blood serum or tissue
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 signed the informed consent form.; Other Names: Multiomics in blood serum or tissue
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 signed the informed consent form.; Other Names: Multiomics in blood serum or tissue
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 signed the informed consent form.; Other Names: Multiomics in blood serum or tissue

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: LanZhou University; First Affiliated Hospital, Sun Yat-Sen University; Wuhan Union Hospital, China; First Affiliated Hospital of Guangxi Medical University
• Investigators: Principal Investigator: Ning Zhong, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: September 10, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Neoplasms; Pancreatitis; Neuroendocrine Tumors; Pancreatic Diseases
• Other Study ID Numbers: 2023SDU-QILU-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No