2022-05-22
2026-12-31
2027-04-30
60
NCT06777030
IRCCS Azienda Ospedaliero-Universitaria di Bologna
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OBSERVATIONAL
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.
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;
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 Registration Dates | Results Reporting Dates | Study Record Updates |
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2025-01-10 | N/A | 2025-01-10 |
2025-01-10 | N/A | 2025-01-15 |
2025-01-15 | N/A | 2024-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
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Primary Outcome Measures | Measure Description | Time Frame |
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Characterise the extracellular vesicle/exosome content of patients with pancreatic carcinoma. | 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. |
Secondary Outcome Measures | Measure Description | Time Frame |
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This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Leonardo Henry Umberto Eusebi, MD Phone Number: 0039 0512143338 Email: leonardo.eusebi@unibo.it |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available