An observational study in Pancreatic Ductal Adenocarcinoma (PDAC), Intraductal Papillary Mucinous Neoplasm of Pancreas and Pancreatic Intraepithelial Neoplasia, sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Observational
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.
Pancreatic ductal adenocarcinoma (PDAC) is currently one of the leading causes of cancer-related mortality worldwide and is characterized by late diagnosis, high biological aggressiveness, and marked resistance to systemic therapies. Epidemiologic projections indicate that, by 2030, PDAC will become the second most common cause of cancer death in Western countries, highlighting the need for improved early-diagnosis strategies and therapeutic interventions. Most PDACs arise from non-invasive precursor lesions through a multistep neoplastic transformation process. Key precursor entities include pancreatic intraepithelial neoplasia (PanIN) and mucinous cystic lesions, particularly intraductal papillary mucinous neoplasms (IPMN), which are clinically detectable by imaging, biologically heterogeneous, and associated with variable malignant potential. The widespread use of high-resolution imaging has increased incidental detection of pancreatic cysts, but only a subset of these lesions will progress to invasive carcinoma, making clinical management challenging.
In this context, the identification of reliable molecular biomarkers capable of predicting progression to invasive carcinoma is a clinical and scientific priority. This single-center, prospective observational translational study will include three arms: patients with IPMN, patients with PanIN, and patients with PDAC confirmed by histopathologic examination after pancreatic resection. Residual tissue not needed for diagnostic histopathology will be processed following standardized procedures to ensure high-quality biospecimens and full traceability. Fresh samples will be used for isolation of tumor stem-like cells and establishment of three-dimensional cultures (tumorspheres and organoids); additional material will be fixed in formalin and embedded in paraffin (FFPE) for histopathologic and immunohistochemical analyses.
Molecular analyses will comprise next-generation sequencing (NGS) to identify somatic mutations, genomic instability, tumor mutational burden (TMB), and alterations in key oncogenic genes and pathways; RNA-sequencing (RNA-seq) to characterize transcriptional programs associated with neoplastic transformation; protein expression studies by immunofluorescence, immunohistochemistry, and Western blot focusing on proliferation, apoptosis, and tumor stemness markers; advanced cellular imaging to study proliferation, survival, invasiveness, and metabolic adaptation under stress; and in-vitro pharmacologic assays to assess sensitivity of patient-derived models to inhibitors targeting the identified biomarkers. Statistical analyses will include Monte Carlo-based sample-size estimation, group comparisons using parametric and non-parametric tests, logistic regression models, ROC curve analyses, and high-dimensional bioinformatic pipelines for differential expression, clustering, and multivariate pattern recognition. The ultimate aim is to define and validate molecular signatures predictive of progression toward PDAC, correlate them with clinical and pathological features, and generate organoid models for preclinical studies in precision oncology.
32 studies on the registry are indexed under Pancreatic Intraductal Neoplasms; 21 are open to participants now.
This study's planned enrollment of 180 is below the median of 586 across 17 observational studies indexed under Pancreatic Intraductal Neoplasms.
Browse Pancreatic Intraductal Neoplasms studies →Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis is the lead sponsor of 55 studies on the registry; 19 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
Time frame: Up to 36 months from surgery
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.
Time frame: Up to 36 months from surgery
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.
Time frame: Up to 36 months
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
Time frame: Up to 36 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis