Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pancreatic elastase-1 in blood serum.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma, Pancreatic Diseases, Pancreatic Elastase 1, Pancreatic Neuroendocrine Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.
Overview
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.
Interventions
- 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.
Primary outcome measures
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [Time frame: 2 years]
Secondary outcome measures (4)
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [Time frame: 2 years]
- The content of elastase 1 [Time frame: 2 years]
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [Time frame: 2 years]
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values) [Time frame: 2 years]
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 CA19-9.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Ning Zhong — Jinan
Identifiers
NCT: NCT06041009 · 2023SDU-QILU-4