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RecruitingNCT06041009

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

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

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
2,100 (estimated)
Sponsor
Qilu Hospital of Shandong University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPancreatic elastase-1 in blood serumSerum 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.

Timeline

Start date
2023-05-05
Primary completion
2025-09-30
Completion
2025-09-30
First posted
2023-09-18
Last updated
2024-10-18

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06041009. Inclusion in this directory is not an endorsement.