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NCT Number: NCT06777030

Role of Exosomes in Pancreatic Cancer Progression

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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;

Study contacts

Contact information is provided by the study sponsor or research team.

Leonardo Henry Umberto Eusebi, MD

CONTACT

[email protected]

0039 0512143338

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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