Pancreatic ductal adenocarcinoma (PDAC) is one of the cancers with the poorest prognosis and is often diagnosed at an advanced stage, resulting in very low 5-year survival rates. Many PDACs arise from non-invasive precursor lesions that develop over years, including pancreatic intraepithelial neoplasia (PanIN) and intraductal papillary mucinous neoplasms (IPMN). Only a minority of pancreatic cystic lesions progress to invasive carcinoma, and current clinical and radiologic criteria have limited accuracy in predicting which patients are at high risk. This observational translational study will enroll adult patients undergoing pancreatic surgical resection for suspected pancreatic neoplasm (IPMN, PanIN, or PDAC) at IRCCS "Saverio de Bellis". Residual tumor tissue not required for diagnostic purposes, and when available adjacent non-neoplastic tissue, will be collected, coded, and pseudonymized for molecular analyses. Tumor cells will be used to generate three-dimensional cultures (tumorspheres and organoids) and will undergo genomic characterization by next-generation sequencing, RNA-sequencing-based transcriptomic profiling, protein expression analyses, advanced imaging, and in-vitro drug response assays. The main goal is to identify and validate molecular biomarkers predictive of progression to PDAC, improve risk stratification of patients with pancreatic precursor lesions, and support the development of innovative precision medicine strategies.
Age ≥ 18 years.
Patients undergoing pancreatic surgical resection for suspected pancreatic neoplasm.
Histopathologic diagnosis of intraductal papillary mucinous neoplasm (IPMN), pancreatic intraepithelial neoplasia (PanIN), or pancreatic ductal adenocarcinoma (PDAC).
Availability of residual tumor tissue from the surgical procedure not required for diagnostic purposes.
Age < 18 years.
Surgical procedure performed for neoplasms other than IPMN, PanIN, or PDAC.
Absence of written informed consent.
The study population consists of adult patients (≥18 years) referred to the IRCCS "Saverio de Bellis" for pancreatic surgical resection due to suspected pancreatic neoplasm. Eligible participants are those with a histopathologic diagnosis of intraductal papillary mucinous neoplasm (IPMN), pancreatic intraepithelial neoplasia (PanIN), or pancreatic ductal adenocarcinoma (PDAC), with availability of residual tumor tissue not required for routine diagnostics and who have provided written informed consent for use of biological samples in translational research.
Cohort
Prospective
Not listed
Molecular biomarkers predictive of progression to pancreatic ductal adenocarcinoma (PDAC
Identification of genomic, transcriptomic, and proteomic biomarkers associated with progression from pancreatic precursor lesions (IPMN, PanIN) to PDAC, based on NGS, RNA seq, protein expression assays, and advanced imaging in patient derived tumorspheres and organoids.
Protein level validation of candidate biomarkers
Validation of selected predictive biomarkers at the protein level by immunohistochemistry, immunofluorescence, and Western blot in tissue and organoid samples from IPMN, PanIN, and PDAC patients.
Association between biomarker profiles and tumor progression
Evaluation of correlations between biomarker expression profiles and clinical, histopathologic, and imaging indicators of tumor progression, using logistic regression and ROC curve analyses.
Establishment of patient derived organoid models for preclinical studies
Generation and characterization of stable patient derived tumorsphere and organoid models from IPMN, PanIN, and PDAC samples suitable for preclinical drug testing and precision medicine applications
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