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
Adult men or women aged ≥18 years at the time of plasma sample collection.
Classification as at increased risk for pancreatic ductal adenocarcinoma (PDAC) due to familial pancreatic cancer or hereditary pancreatic cancer syndrome
Classification as at increased risk for pancreatic ductal adenocarcinoma (PDAC) due to the presence of one (or more) mucinous pancreatic cystic lesion(s).
Availability of stored plasma samples collected as part of routine clinical care or surveillance and archived in the institutional biobank.
Absence or insufficient quality/quantity of stored plasma samples for laboratory analysis.
Lack of clinical data required for cohort classification and/or outcome assessment.
History of pancreatic surgery or interventional procedures prior to plasma sample collection.
Concurrent active malignancy at the time of sample collection, other than non-melanoma skin cancer.
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.
Cohort
Retrospective
PANXEON
Diagnostic testA 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
Specificity
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
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
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