Predictive Biomarkers for Early Diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC)

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Conditions studied: Pancreatic Ductal Adenocarcinoma (PDAC), Intraductal Papillary Mucinous Neoplasm of Pancreas, Pancreatic Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT07709052

Run by

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

People needed

180

Starts

2026-09-01

Expected to finish

2028-09-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Signed written informed consent for the use of biological samples for research purposes

You may not qualify if…

• Age < 18 years.
• Surgical procedure performed for neoplasms other than IPMN, PanIN, or PDAC.
• Absence of written informed consent.

Full record on ClinicalTrials.gov

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