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

Sponsor
Università Vita-Salute San Raffaele
Study ID
NCT07700992
Status
Recruiting
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Conditions

  • Familial Pancreatic Cancer
  • Familial Pancreatic Carcinoma
  • Hereditary Pancreatic Cancer
  • Hereditary Pancreatitis
  • Intraductal Papillary Mucinous Neoplasm
  • Pancreas Adenocarcinoma
  • Pancreas Cancer
  • Pancreas Cyst
  • Pancreas Neoplasm
  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jul 14, 2026
Start date
Jun 3, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2031
Completion
Jan 30, 2032

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Familial pancreatic cancer (FPC)
    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
  • Arm: Hereditary pancreatic cancer (HPC)
    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
  • Arm: Mucinous Pancreatic Neoplasms (MPN)
    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)

Primary Outcome Measure

Sensitivity [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

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