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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Age < 18 years.

Surgical procedure performed for neoplasms other than IPMN, PanIN, or PDAC.

Absence of written informed consent.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

180 Participants
are grouped into 3 trial groups

Locations

This trial has no locations