Diagnostic Utility of Protein Biomarkers in Pancreatic Ductal Adenocarcinoma

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy frequently diagnosed at advanced stages, when curative treatment options are limited. Early diagnosis remains challenging, particularly when distinguishing PDAC from benign inflammatory conditions, such as chronic pancreatitis, or from mucinous pancreatic lesions with malignant potential. Although carbohydrate antigen 19-9 (CA 19-9) is widely used in clinical practice, its diagnostic performance is limited, especially in early-stage disease and in differentiating malignant from benign pancreatic conditions. Emerging blood-based protein biomarkers involved in inflammation, tumor progression, cell adhesion, and tissue remodeling may improve the diagnostic evaluation of pancreatic diseases. The combined assessment of multiple biomarkers, particularly alongside CA 19-9, may provide greater diagnostic accuracy than individual markers. This study is designed as a prospective, multicenter, observational cohort study conducted at two tertiary medical centers in Romania: Institute of Gastroenterology and Hepatology, Saint Spiridon County Clinical Emergency Hospital in Iasi and Fundeni Clinical Institute in Bucharest. Patients will be enrolled into four diagnostic groups according to their underlying pancreatic condition: PDAC, chronic pancreatitis, intraductal papillary mucinous neoplasms (IPMNs), and mucinous cystic neoplasms (MCNs). For secondary analyses, these groups may be classified into malignant (PDAC), premalignant (IPMN and MCN), and benign inflammatory (chronic pancreatitis) categories. At enrollment, demographic characteristics, relevant medical history, clinical findings, laboratory parameters, and imaging data will be collected. Disease-related information, including pancreatic lesion characteristics, diagnostic confirmation, and treatment history, will also be recorded. Blood samples will be collected at both participating centers before the initiation of oncological or interventional treatment. Protein biomarker measurements will be performed centrally at the Immunology Laboratory of Sf. Spiridon County Clinical Emergency Hospital in Iași, using a validated Luminex-based multiplex assay in accordance with the manufacturer's instructions and standardized laboratory procedures. The investigated protein biomarkers include growth differentiation factor-15 (GDF-15), intercellular adhesion molecule-1 (ICAM-1), osteopontin, C-X-C motif chemokine ligand 10 (CXCL10), hepatocyte growth …

Intervention public domain (ClinicalTrials.gov)

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.

Arm public domain (ClinicalTrials.gov)

Pancreatic Ductal Adenocarcinoma (PDAC) (): Adult patients diagnosed with histologically confirmed pancreatic ductal adenocarcinoma (PDAC). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis.

Arm public domain (ClinicalTrials.gov)

Chronic Pancreatitis (): Adult patients diagnosed with chronic pancreatitis, including mass-forming chronic pancreatitis. Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis.

Arm public domain (ClinicalTrials.gov)

Intraductal Papillary Mucinous Neoplasm (IPMN) (): Adult patients diagnosed with intraductal papillary mucinous neoplasms (IPMNs). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis.

Arm public domain (ClinicalTrials.gov)

Mucinous Cystic Neoplasm (MCN) (): Adult patients diagnosed with mucinous cystic neoplasms (MCNs). Clinical, imaging, and laboratory data will be collected, and blood samples will be obtained for protein biomarker analysis.

Primary outcome public domain (ClinicalTrials.gov)

Diagnostic Accuracy of Blood-Based Protein Biomarkers for Pancreatic Ductal Adenocarcinoma. The diagnostic accuracy of circulating protein biomarkers (GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A) for identifying pancreatic ductal adenocarcinoma (PDAC) will be assessed using receiver operating characteristic (ROC) curve analysis. Diagnostic performance will be quantified by the area under the ROC curve (AUC), sensitivity, specificity, and predictive values. Time frame: At baseline (study enrollment, prior to oncological or interventional treatment).

Secondary outcome public domain (ClinicalTrials.gov)

Differences in Plasma Protein Biomarker Levels Across Pancreatic Disease Groups. Time frame: At baseline (study enrollment).

Secondary outcome public domain (ClinicalTrials.gov)

Diagnostic Performance of Combined Protein Biomarkers and CA 19-9. Time frame: At baseline (study enrollment).

Secondary outcome public domain (ClinicalTrials.gov)

Diagnostic Discrimination Between Pancreatic Ductal Adenocarcinoma and Benign or Mucinous Pancreatic Conditions. Time frame: At baseline (study enrollment).

Eligibility public domain (ClinicalTrials.gov)

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

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 100 participants (estimated).