← Back to all trials
Recruiting
NCT07875582
Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma
Conditions: Pancreatic Cancer, Chronic Pancreatitis, Intraductal Papillary Mucinous Neoplasm, Mucinous Cystic Neoplasm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Grigore T. Popa University of Medicine and Pharmacy
Location: Saint Spiridon Emergency County Hospital Iași
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.
Eligibility Criteria
Inclusion criteria:
* Adults aged 18 years or older
* Diagnosis of pancreatic ductal adenocarcinoma (PDAC), chronic pancreatitis, intraductal papillary mucinous neoplasm (IPMN), or mucinous cystic neoplasm (MCN)
* Histopathological confirmation mandatory for PDAC and optional for benign pancreatic conditions
* Diagnosis of benign pancreatic conditions confirmed by imaging criteria and/or a minimum clinical follow-up of 12 months
* Written informed consent
Exclusion criteria:
* Less than 3 months since resolution of the most recent episode of acute pancreatitis
* Other active malignancies
* Severe systemic inflammatory diseases
* Oncological treatment initiated before blood sample collection, including chemotherapy or surgical resection
* Refusal to participate
Source: ClinicalTrials.gov (NCT07875582). StuddyBuddy aggregates publicly available trial information.