Role of Exosomes in Pancreatic Cancer Progression

January 10, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
The present pilot study is set up with the objective of identifying circulating markers in the biological fluids (blood and urine) of subjects with pancreatic carcinoma and their association with disease stage, to evaluate their potential use as predictive and diagnostic markers for this tumor of difficult early diagnosis and often inauspicious prognosis.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study is cross-sectional, single-center, spontaneous, in human tissues. It is a pilot study to gather evidence on the content of extracellular vesicles/exosomes in patients with pancreatic cancer.

The study will be performed on tumor tissue, blood and urine samples. Tissue will be obtained by needle biopsy (fine needle biopsy - FNB) during echoendoscopic examination.

The study aims to characterize the content of extracellular vesicles/exosomes in the biological fluids of subjects with pancreatic cancer with the goal of identifying new markers for this disease. To this end, the following will be carried out:

  • an ex vivo and in vitro characterization study of the secretion of these extracellular vesicles/exosomes with analysis of their contents in terms of proteins and nucleic acids;
  • a study of the mechanisms of epithelial-mesenchymal transition (EMT), invasion and aggressiveness to highlight a possible association between the secretion of these vesicles and the oncological stage of pancreatic carcinoma;

Study Type

Observational

Enrollment (Estimated)

60

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

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

No

Sampling Method

Non-Probability Sample

Study Population

The study involves the enrollment of patients hospitalized for diagnostic-therapeutic evaluation of pancreatic neoformation. In particular, patients will be included for whom biopsy sampling of the pancreatic lesion by means of an ultrasound-guided needle biopsy is planned during hospitalization.

Description

Inclusion criteria:

  • People with pancreatic cancer
  • 18 years old
  • Obtaining informed consent.

Exclusion criteria:

  • Patients who do not need or cannot perform endoscopy with biopsy sampling;
  • patients with a previous or active neoplastic pathology, different from pancreatic neoplasia.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterise the extracellular vesicle/exosome content of patients with pancreatic carcinoma.
Time Frame: At baseline, visit V1.

The study aims to characterize the extracellular vesicles/exosomes content in the biological fluids of subjects suffering from pancreatic carcinoma with the aim of identifying new markers for this disease. To this end, the following will be carried out:

  • a study of ex vivo and in vitro characterisation of the secretion of these extracellular vesicles/exosomes with analysis of their content in terms of proteins and nucleic acids;
  • a study of mesenchymal epithelium transition (EMT), invasion and aggression mechanisms to highlight a possible association between secretion of these vesicles and the oncological stage of pancreatic carcinoma;
At baseline, visit V1.

Collaborators and Investigators

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Leonardo Henry Umberto Eusebi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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)

May 22, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXOPanc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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