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NCT07709052Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
180 (estimated)
First submitted
13 Jul 2026
Start date
1 Sept 2026
Primary completion date
1 Sept 2027
Lead sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
NCT number
NCT07709052

What you commit to

  • Study type: Observational
  • Planned participants: 180
  • From 1 Sept 2026 to the primary completion date, 1 Sept 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Age

  • Age \< 18 years.

Other

  • Absence of written informed consent.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.