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Recruiting Observational

A Liquid Biopsy for Pancreatic Cancer Early-detection and Disease Monitoring

NCT07700992 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-06-03
Last updated
2026-07-14

Condition(s) studied

Familial Pancreatic CancerFamilial Pancreatic CarcinomaHereditary Pancreatic CancerHereditary PancreatitisPancreas CancerPancreas NeoplasmPancreas AdenocarcinomaPancreas CystPancreatic NeoplasmsIntraductal Papillary Mucinous Neoplasm

Investigational drug(s) / intervention(s)

PANXEON

PANXEON: A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Sensitivity — Through study completion, an average of 1 year
    True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Hospital Milan MI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07700992 on ClinicalTrials.gov ↗ ← All trials in Italy