An observational study in Familial Pancreatic Cancer, Familial Pancreatic Carcinoma and Hereditary Pancreatic Cancer, sponsored by Università Vita-Salute San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Università Vita-Salute San Raffaele · Observational
Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal malignancy characterized by an asymptomatic early phase, late diagnosis, and poor survival, particularly in individuals who develop disease outside the context of early-stage detection. Early detection strategies are currently limited to imaging-based surveillance (MRI and endoscopic ultrasound) in selected high-risk populations, but these approaches are invasive, costly, and suboptimal in sensitivity. The aim of this study is to evaluate circulating cell-free and exosome-bound microRNAs as non-invasive biomarkers of PDAC risk and disease biology
Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal malignancy characterized by an asymptomatic early phase, late diagnosis, and poor survival, particularly in individuals who develop disease outside the context of early-stage detection. Early detection strategies are currently limited to imaging-based surveillance (MRI and endoscopic ultrasound) in selected high-risk populations-including individuals with hereditary or familial pancreatic cancer and those with mucinous pancreatic cystic lesions-but these approaches are invasive, costly, and suboptimal in sensitivity.
The aim of this study is to evaluate circulating cell-free and exosome-bound microRNAs as non-invasive biomarkers of PDAC risk and disease biology, with the hypothesis that combined microRNA profiling can improve molecular risk stratification and potentially anticipate disease progression compared with standard imaging-based surveillance alone. The study population will include adult men and women (≥18 years) at increased risk for PDAC due to familial or hereditary predisposition or mucinous pancreatic cysts, with generally stable health status and existing clinical follow-up; no vulnerable populations are specifically targeted.
No medicinal products or medical devices are administered in this study. The procedure under investigation consists exclusively of laboratory-based measurement of microRNA expression from previously collected plasma samples, using validated exosome isolation and quantification techniques, with no impact on clinical management. Available preliminary and published data demonstrate that combined cell-free and exosomal microRNA signatures can detect early-stage PDAC with high accuracy and show dynamic behavior during disease progression and treatment, supporting their relevance for risk stratification and disease monitoring. Clinical, demographic, and laboratory data will be retrieved.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.
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Selection of participants will be equitable and non-discriminatory, with no exclusion based on sex, ethnicity, or socioeconomic status. Pediatric populations are excluded due to the rarity of PDAC risk conditions in this group and the absence of relevant stored biospecimens.
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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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This term refers to individuals who are at a higher risk of developing pancreatic cancer based on their family history. There are two main risk categories: * 2 relatives with pancreatic cancer, who are first-degree relative of each other, and at least one should be a first degree relative of the individual for whom surveillance is being considered * 3 or more relatives with pancreatic cancer, regardless of the degree
Diagnostic Test: PANXEON
This terms encompasses all individuals who are at an increased risk of developing pancreatic cancer based on the presence of a pathogenic (or likely pathogenic) germline variant. More specifically: * All individuals with a pathogenic (or likely pathogenic) germline variant in Serine/Threonine Kinase 11 (STK11), cyclin-dependent kinase inhibitor 2A (CDKN2A), Ataxia-Telangiectasia Mutated (ATM), and Breast cancer type 2 (BRCA2) genes, regardless of their family history of pancreatic cancer * Individuals who have both (i) a pathogenic (or likely pathogenic) germline variant in Breast cancer type 1 (BRCA1), Partner and Localizer of BRCA2 (PALB2), Mutator L Homolog 1 (MLH1), Mutator S Homolog 2 (MSH2), Mutator S Homolog 6 (MSH6), Postmeiotic Segregation 1 Homolog 2 (PMS2), or Epithelial Cell Adhesion Molecule (EPCAM) genes; and (ii) at least one relative diagnosed with pancreatic cancer
Diagnostic Test: PANXEON
This term refers collectively to cystic lesions of the pancreas that confer an increased risk of developing pancreatic cancer. Collectively, this term encompasses both Intraductal Pancreatic Mucinous Neoplasms (IPMN) and Mucinous Cystic Neoplasias (MCNs)
Diagnostic Test: PANXEON
A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples
Sensitivity
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Time frame: Through study completion, an average of 1 year
Specificity
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Time frame: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided — Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
Started Jun 2026 (actual). Primary completion is estimated for Dec 2031, 66 months after the start.
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Università Vita-Salute San Raffaele