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

July 13, 2026 updated by: Alessandro Mannucci, Università Vita-Salute San Raffaele

An Exosome-based and Machine-learning-powered Liquid Biopsy for Pancreatic Cancer Early-detection and Disease Monitoring

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: PANXEON
A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples
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
Diagnostic test: PANXEON
A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples
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)
Diagnostic test: PANXEON
A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Through study completion, an average of 1 year
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
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)
Time Frame: Through study completion, an average of 1 year
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Investigators

  • Principal Investigator: Alessandro Mannucci, MD, Università Vita-Salute San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

January 30, 2032

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANXEON/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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