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RECRUITING
NCT05798338

Characterization of Extracellular Vesicles in Breast Cancer Patients

Sponsor: Istituti Clinici Scientifici Maugeri SpA

View on ClinicalTrials.gov

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.

Official title: Characterization of Extracellular Vesicles in Breast Cancer Patients' Plasma by Single Molecule Detection Array (SiMoA) Digital ELISA

Key Details

Gender

FEMALE

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

105

Start Date

2020-12-01

Completion Date

2026-09-30

Last Updated

2025-11-25

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

Blood sample

Analysis of plasma in order to quantify and characterize EVs

Locations (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy