An observational study in Pancreatic Cancer, Chronic Pancreatitis and Intraductal Papillary Mucinous Neoplasm, sponsored by Grigore T. Popa University of Medicine and Pharmacy. Recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Grigore T. Popa University of Medicine and Pharmacy · Observational
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.
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 factor (HGF), Nectin-4, periostin, and vascular endothelial growth factor A (VEGF-A). CA 19-9 and routine laboratory parameters will also be assessed.
Statistical analyses will include descriptive and comparative methods to examine differences in plasma biomarker concentrations across the diagnostic groups. Diagnostic performance will be evaluated using receiver operating characteristic (ROC) curve analysis and related measures of diagnostic accuracy. Multivariable logistic regression will be used to investigate the independent diagnostic contribution of individual biomarkers and their combined performance with CA 19-9.
The study is observational, and all diagnostic and therapeutic decisions will remain part of routine clinical care. No experimental treatments will be administered. Patient information will be coded and handled confidentially in accordance with applicable data protection regulations.
The findings may contribute to the development of more accurate blood-based diagnostic strategies for differentiating pancreatic cancer from benign and potentially premalignant pancreatic diseases.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 636 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Grigore T. Popa University of Medicine and Pharmacy is the lead sponsor of 32 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of patients recruited from two tertiary referral centers in Romania: the Institute of Gastroenterology and Hepatology at Sf. Spiridon County Clinical Emergency Hospital in Iași and Fundeni Clinical Institute in Bucharest. Participants will be prospectively enrolled during routine clinical care in the gastroenterology departments of the participating institutions.
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Exclusion criteria:
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.
Diagnostic Test: Blood-Based Protein Biomarker Assessment
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.
Diagnostic Test: Blood-Based Protein Biomarker Assessment
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.
Diagnostic Test: Blood-Based Protein Biomarker Assessment
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.
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.
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)
Differences in Plasma Protein Biomarker Levels Across Pancreatic Disease Groups
Plasma concentrations of GDF-15, ICAM-1, osteopontin, CXCL10, HGF, Nectin-4, periostin, and VEGF-A will be compared among patients with pancreatic ductal adenocarcinoma, chronic pancreatitis, intraductal papillary mucinous neoplasms (IPMNs), and mucinous cystic neoplasms (MCNs). Differences in biomarker concentrations between the four diagnostic groups will be assessed using appropriate statistical tests.
Time frame: At baseline (study enrollment)
Diagnostic Performance of Combined Protein Biomarkers and CA 19-9
The diagnostic performance of protein biomarkers combined with CA 19-9 will be compared with that of individual biomarkers. Receiver operating characteristic (ROC) curve analysis will be used to assess the area under the curve (AUC), sensitivity, specificity, and predictive values of combined biomarker models for detecting pancreatic ductal adenocarcinoma.
Time frame: At baseline (study enrollment)
Diagnostic Discrimination Between Pancreatic Ductal Adenocarcinoma and Benign or Mucinous Pancreatic Conditions
The ability of circulating protein biomarkers to differentiate pancreatic ductal adenocarcinoma from chronic pancreatitis and from mucinous pancreatic lesions (IPMNs and MCNs) will be evaluated. Separate diagnostic comparisons will be performed for PDAC versus chronic pancreatitis and PDAC versus mucinous pancreatic lesions, using ROC curve analysis and diagnostic accuracy measures.
Time frame: At baseline (study enrollment)
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to patient confidentiality and data protection considerations. The data will be used exclusively for the purposes of the current study, in accordance with the informed consent provided by participants and applicable data protection regulations.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.
Of 276 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 86 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 206. This study's planned 12 months is below that.
Counting every sponsor, half of 305 studies reached it within 83 months; a quarter within 40 and three quarters within 206.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Grigore T. Popa University of Medicine and Pharmacy