Clinical trial · Observational
Predictive Biomarkers for Early Diagnosis of Pancreatic Ductal Adenocarcinoma (PDAC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraductal Papillary Mucinous Neoplasm of Pancreas | Pancreatic Intraductal Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Pancreatic Intraepithelial Neoplasia | Pancreatic Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- IPMN Cohort
- description
- Adult patients undergoing pancreatic resection with histopathologic diagnosis of intraductal papillary mucinous neoplasm (IPMN); residual tumor tissue and, when available, adjacent non neoplastic tissue will be collected for molecular analyses and organoid generation
- label
- PanIN Cohort
- description
- Adult patients undergoing pancreatic resection with histopathologic diagnosis of pancreatic intraepithelial neoplasia (PanIN); residual tissue will be used for genomic, transcriptomic, proteomic, and functional studies in patient derived models
- label
- PDAC Cohort
- description
- Adult patients undergoing pancreatic resection with histopathologic diagnosis of pancreatic ductal adenocarcinoma (PDAC); biospecimens will be processed for comprehensive molecular characterization and comparison with precursor lesions
Primary outcomes (1)
- measure
- Molecular biomarkers predictive of progression to pancreatic ductal adenocarcinoma (PDAC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Age \< 18 years. * Surgical procedure performed for neoplasms other than IPMN, PanIN, or PDAC. * Absence of written informed consent.
References
Publications (5)
- BACKGROUNDMarsoner K, Haybaeck J, Csengeri D, Waha JE, Schagerl J, Langeder R, Mischinger HJ, Kornprat P. Pancreatic resection for intraductal papillary mucinous neoplasm- a thirteen-year single center experience. BMC Cancer. 2016 Nov 4;16(1):844. doi: 10.1186/s12885-016-2887-8. PMID 27809876
- BACKGROUNDRahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas. 2025 Jul 1;54(6):e530-e536. doi: 10.1097/MPA.0000000000002489. PMID 40245290
- BACKGROUNDMuraki T, Jang KT, Reid MD, Pehlivanoglu B, Memis B, Basturk O, Mittal P, Kooby D, Maithel SK, Sarmiento JM, Christians K, Tsai S, Evans D, Adsay V. Pancreatic ductal adenocarcinomas associated with intraductal papillary mucinous neoplasms (IPMNs) versus pseudo-IPMNs: relative frequency, clinicopathologic characteristics and differential diagnosis. Mod Pathol. 2022 Jan;35(1):96-105. doi: 10.1038/s41379-021-00902-x. Epub 2021 Sep 13. PMID 34518632
- BACKGROUNDTaherian M, Wang H, Wang H. Pancreatic Ductal Adenocarcinoma: Molecular Pathology and Predictive Biomarkers. Cells. 2022 Sep 29;11(19):3068. doi: 10.3390/cells11193068. PMID 36231030
- BACKGROUNDSiegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12. PMID 35020204