MedTrace Logo

Characterization of Extracellular Vesicles in Breast Cancer Patients

NCT05798338 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2025-11-25

No results posted yet for this study

Summary

Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from cells and mediators of intercellular cross-talk. In breast cancer (BC), EVs seem to be involved in the tumor microenvironment's shaping, in cancer cells invasion and in the set-up of metastasis.

Clinical studies have provided initial evidence that these vesicles may have a prognostic and predictive value in breast cancer. Considering their ubiquitous presence in body fluids and their minimally invasive assessment through blood sampling, EVs could have a potential as liquid biopsy-derived biomarkers. Their quantification though is a complex task requiring complicated and time-consuming pre-analytical procedures of EVs isolation.

This protocol want to develop a new method for the detection of tumor-derived-EVs associated proteins, based on the use of Single Molecule Array (SiMoA), a digital ELISA technology able to detect and quantify extremely low concentrations of target proteins or particles.

The aim of this study is to evaluate how this new technology can allow the quantification of EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information.

Conditions

Interventions

DIAGNOSTIC_TEST

Blood sample

Analysis of plasma in order to quantify and characterize EVs

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-09-30
Completion
2026-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05798338 on ClinicalTrials.gov