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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pancreatic elastase-1 in blood serum

Treatment groups

2,100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Qilu Hospital of Shandong University

Lead sponsor

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