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

NCT06041009 | Recruiting

• 1 other identifier: 2023SDU-QILU-4
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)

  2 years

• The content of elastase 1

  2 years

• The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)

  2 years

• The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)

  2 years

Study Arms (6)

Patients with PDAC

Diagnostic Test: Pancreatic elastase-1 in blood serum

Individuals at high risk for PDAC

Diagnostic Test: Pancreatic elastase-1 in blood serum

Group of neuroendocrine neoplasm of pancreas

Diagnostic Test: Pancreatic elastase-1 in blood serum

Group of solid pseudopapillary tumor of pancreas

Diagnostic Test: Pancreatic elastase-1 in blood serum

Group of abnormally elevated CA19-9

Diagnostic Test: Pancreatic elastase-1 in blood serum

Controls without pancreatic disease or elevated CA19-9

Diagnostic Test: Pancreatic elastase-1 in blood serum

Interventions

Pancreatic elastase-1 in blood serum DIAGNOSTIC_TEST

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.

Also known as: Multiomics in blood serum or tissue

Controls without pancreatic disease or elevated CA19-9; Group of abnormally elevated CA19-9; Group of neuroendocrine neoplasm of pancreas; Group of solid pseudopapillary tumor of pancreas; Individuals at high risk for PDAC; Patients with PDAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Case groups (matching any of the following):
• Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.
• Patients who are the high-risk group of pancreatic cancer.
• Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• LanZhou University: collaborator

Study Sites (1)

Ning Zhong

Jinan, Shandong, 250063, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and punctured tissue will be collected.

MeSH Terms

Conditions

Pancreatic Diseases; Adenoma, Islet Cell; Pancreatitis; Pancreatic Neoplasms

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Digestive System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Ning Zhong, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Li, MD

CONTACT

18560086106; qilulizhen@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 18, 2023
• Study Start: May 5, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)