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

Shandong University

Status: Enrolling

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

Treatments: Diagnostic Test: Pancreatic elastase-1 in blood serum

Study type: Observational

Funder types: Other

Identifiers

NCT06041009

2023SDU-QILU-4

Details and patient eligibility

About

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.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,100 participants in 6 patient groups

Patients with PDAC

Treatment:

Diagnostic Test: Pancreatic elastase-1 in blood serum

Individuals at high risk for PDAC

Treatment:

Diagnostic Test: Pancreatic elastase-1 in blood serum

Group of neuroendocrine neoplasm of pancreas

Treatment:

Diagnostic Test: Pancreatic elastase-1 in blood serum

Group of solid pseudopapillary tumor of pancreas

Treatment:

Diagnostic Test: Pancreatic elastase-1 in blood serum

Group of abnormally elevated CA19-9

Treatment:

Diagnostic Test: Pancreatic elastase-1 in blood serum

Controls without pancreatic disease or elevated CA19-9

Treatment:

Diagnostic Test: Pancreatic elastase-1 in blood serum