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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041009
• Other study ID #: 2023SDU-QILU-4
• Status: Recruiting
• Start date: December 20, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: July 2023
• Source: Qilu Hospital of Shandong University
• Contact: Zhen Li, MD
• Phone: 18560086106
• Email: qilulizhen[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Diseases
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• Pancreatic Neuroendocrine Tumor
• Pancreatitis

Intervention

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.

Locations

Country	Name	City	State
China	Ning Zhong	Jinan	Shandong

Sponsors (5)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital, Sun Yat-Sen University, LanZhou University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The content of elastase 1	The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)	2 years
Secondary	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
Secondary	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