Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with PDAC
|
Diagnostic Test: Pancreatic elastase-1 in blood serum
Serum 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.
Other Names:
|
| Individuals at high risk for PDAC
|
Diagnostic Test: Pancreatic elastase-1 in blood serum
Serum 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.
Other Names:
|
| Group of neuroendocrine neoplasm of pancreas
|
Diagnostic Test: Pancreatic elastase-1 in blood serum
Serum 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.
Other Names:
|
| Group of solid pseudopapillary tumor of pancreas
|
Diagnostic Test: Pancreatic elastase-1 in blood serum
Serum 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.
Other Names:
|
| Group of abnormally elevated CA19-9
|
Diagnostic Test: Pancreatic elastase-1 in blood serum
Serum 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.
Other Names:
|
| Controls without pancreatic disease or elevated CA19-9
|
Diagnostic Test: Pancreatic elastase-1 in blood serum
Serum 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [2 years]
The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.
Secondary Outcome Measures
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [2 years]
The diagnostic value of diagnostic model versus EUS or other imaging examinations combined with diagnostic model in diagnosing PDAC.
- The content of elastase 1 [2 years]
The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [2 years]
The ability of diagnostic models, multi-omics novel tumor markers, and common tumor markers to distinguish PDAC, benign pancreatic disease, borderline malignant disease, patients with abnormally elevated CA199, and controls without pancreatic disease.
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [2 years]
The diagnostic value of the diagnostic model, new tumor markers of multi-omics, and the common tumor markers to distinguish pancreatic tumors of different sites and sizes.
Eligibility Criteria
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 CA19-9.
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ning Zhong | Jinan | Shandong | China | 250063 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
- First Affiliated Hospital, Sun Yat-Sen University
- First Affiliated Hospital of Guangxi Medical University
- Wuhan Union Hospital, China
- LanZhou University
Investigators
- Principal Investigator: Ning Zhong, MD, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023SDU-QILU-4