Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Sponsor
- Qilu Hospital of Shandong University
- Enrollment
- 2100
- Locations
- 1
- Primary Endpoint
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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-
- •Control group:
- •(1) Patients without pancreatic disease assessed by laboratory tests and imaging examinations have no CA19-9 elevation.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
Time Frame: 2 years
The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.
Secondary Outcomes
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)(2 years)
- The content of elastase 1(2 years)