A Liquid Biopsy for Pancreatic Cancer Early-detection and Disease Monitoring
NCT07700992
Summary
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
Eligibility
Inclusion Criteria: * 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. * Availability of relevant clinical and demographic data in institutional medical records sufficient to address study objectives. * Prior provision of informed consent for biobanking and research use of biological samples and data Exclusion Criteria: * 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. * Samples collected outside routine clinical care or not compliant with institutional biobanking and data protection policies.
Conditions11
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NCT07700992