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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
China
Ning Zhong
RECRUITING
Jinan
Contact Information
Primary
Zhen Li, MD
qilulizhen@sdu.edu.cn
18560086106
Time Frame
Start Date: 2023-05-05
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 2100
Treatments
Patients with PDAC
Individuals at high risk for PDAC
Group of neuroendocrine neoplasm of pancreas
Group of solid pseudopapillary tumor of pancreas
Group of abnormally elevated CA19-9
Controls without pancreatic disease or elevated CA19-9
Sponsors
Leads: Qilu Hospital of Shandong University
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, LanZhou University, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University

This content was sourced from clinicaltrials.gov