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Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma: A Prospective Multicenter Observational Study

StatusRecruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
The goal of this prospective multicenter observational study is to evaluate the diagnostic accuracy of blood-based protein biomarkers for detecting pancreatic ductal adenocarcinoma (PDAC) in adults aged 18 years and older. The study will investigate whether these biomarkers can help distinguish pancreatic cancer from chronic pancreatitis and mucinous pancreatic lesions, including intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic neoplasms (MCNs). The main questions it aims to answer are: Can blood-based protein biomarkers accurately identify patients with PDAC and distinguish them from patients with chronic pancreatitis or mucinous pancreatic lesions? Does combining protein biomarkers with CA 19-9 improve diagnostic accuracy compared with using individual biomarkers alone? Are protein biomarker levels associated with tumor stage, tumor size, or the presence of metastases in patients with PDAC? Researchers will compare blood levels of protein biomarkers across four groups of patients: those with PDAC, chronic pancreatitis, IPMNs, and MCNs. The biomarkers will include GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A. Participants will: Provide informed consent before enrollment. Provide an additional blood sample for protein biomarker measurement, collected alongside routine blood tests and before any oncological or interventional treatment. Have relevant clinical information, medical history, laboratory results, and imaging findings collected for analysis.
Trial Details
NCT Number NCT07875582
Lead Sponsor Grigore T. Popa University of Medicine and Pharmacy
Collaborators: Institutul Clinic Fundeni, Sf Spiridon County Clinical Emergency Hospital, Iasi, Romania
Conditions
(from sponsor)
Pancreatic Cancer, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm
Related terms Pancreatic Neoplasms, Pancreatitis, Chronic
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov