Clinical trialObsUnknown
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.
- Outcome
- Outcome unknown
- Phase
- Obs
- Status
- Unknown
- Study type
- Observational
- Start
- 5 May 2023
- Expected end
- 30 September 2025
- Enrollment
- 2,100 participants
- Sites
- 1
- Primary outcomes
- The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 October 2024
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
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.
Arm public domain (ClinicalTrials.gov)
Patients with PDAC ():
Arm public domain (ClinicalTrials.gov)
Individuals at high risk for PDAC ():
Arm public domain (ClinicalTrials.gov)
Group of neuroendocrine neoplasm of pancreas ():
Arm public domain (ClinicalTrials.gov)
Group of solid pseudopapillary tumor of pancreas ():
Arm public domain (ClinicalTrials.gov)
Group of abnormally elevated CA19-9 ():
Arm public domain (ClinicalTrials.gov)
Controls without pancreatic disease or elevated CA19-9 ():
Primary outcome public domain (ClinicalTrials.gov)
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values). The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC. Time frame: 2 years.
Secondary outcome public domain (ClinicalTrials.gov)
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values). Time frame: 2 years.
Secondary outcome public domain (ClinicalTrials.gov)
The content of elastase 1. Time frame: 2 years.
Secondary outcome public domain (ClinicalTrials.gov)
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values). Time frame: 2 years.
Secondary outcome public domain (ClinicalTrials.gov)
The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values). Time frame: 2 years.
Eligibility public domain (ClinicalTrials.gov)
Inclusion Criteria: Case groups (matching any of the following): 1. Patients with pancreatic cancer with recognized diagnostic criteria or conclusions. 2. Patients who are the high-risk group of pancreatic cancer. 3. Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with recognized diagnostic criteria or conclusions. 4. 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: 1. Patients who are younger than 18 years of age. 2. Patients with suspected pancreatic malignant lesions but has no confirmed imaging or pathological diagnosis. 3. Patients who have not signed informed consent.
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 2100 participants (estimated).