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

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma; Pancreatic Elastase 1; Pancreatic Neuroendocrine Tumor; Pancreatitis; Pancreatic Diseases; Pancreatic Neoplasms
• Interventions: Diagnostic Test: Pancreatic elastase-1 in blood serum

• Registration Number: NCT06041009
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-05
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-09-10
• Study First Posted: 2023-09-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PDAC	Pancreatic elastase-1 in blood serum	-
Group of solid pseudopapillary tumor of pancreas	Pancreatic elastase-1 in blood serum	-
Group of abnormally elevated CA19-9	Pancreatic elastase-1 in blood serum	-
Controls without pancreatic disease or elevated CA19-9	Pancreatic elastase-1 in blood serum	-
Group of neuroendocrine neoplasm of pancreas	Pancreatic elastase-1 in blood serum	-
Individuals at high risk for PDAC	Pancreatic elastase-1 in blood serum	-

Primary Outcome Measures

Name	Time	Method
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)	2 years	The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.

Secondary Outcome Measures

Name	Time	Method
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)	2 years	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.
The content of elastase 1	2 years	The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)

Trial Locations

Locations (1)

Ning Zhong; 🇨🇳 Jinan, Shandong, China