Role of Exosomes in Pancreatic Cancer Progression

NCT06777030 | Recruiting

• 1 other identifier: EXOPanc
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples of tumour tissue, blood and urine samples

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Leonardo Henry Umberto Eusebi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo Henry Umberto Eusebi, MD

CONTACT

0039 0512143338; leonardo.eusebi@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: May 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 15, 2025

Record last verified: 2024-12

Locations

IT (1)