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Recruiting NCT06777030

Role of Exosomes in Pancreatic Cancer Progression

Observational Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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;

Primary outcome measures

  • Characterise the extracellular vesicle/exosome content of patients with pancreatic carcinoma. [Time frame: At baseline, visit V1.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna

Identifiers

NCT: NCT06777030 · EXOPanc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗