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RECRUITING
NCT07875582

Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma

Sponsor: Grigore T. Popa University of Medicine and Pharmacy

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of the Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma: A Prospective Multicenter Observational Study to Differentiate Pancreatic Cancer From Chronic Pancreatitis and Mucinous Pancreatic Lesions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-10-08

Completion Date

2027-12

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Blood-Based Protein Biomarker Assessment

Blood samples will be collected for the measurement of circulating protein biomarkers, including GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A, using a validated Luminex-based multiplex assay. CA 19-9 levels will also be assessed. Biomarker concentrations will be compared across the four diagnostic groups to evaluate their ability to differentiate pancreatic ductal adenocarcinoma from chronic pancreatitis and mucinous pancreatic lesions.

Locations (1)

Saint Spiridon Emergency County Hospital

Iași, Romania