Characterization of Extracellular Vesicles in Breast Cancer Patients

NCT05798338 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Phase

Observational

Started

2020-12-01

Last updated

2026-08-26

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Blood sample

Blood sample: Analysis of plasma in order to quantify and characterize EVs

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

90 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Signing of a specific informed consent for participation to the study * Female sex Population 1: * Diagnosis of early breast cancer; * Indication for surgery after multidisciplinary discussion. Population 2: \- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment. Population 3: * Diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging; * Indication to chemotherapy. Exclusion Criteria: Population 1: * Presence of distant metastases * Synchronous presence of a different tumor * Indication to neoadjuvant chemotherapy Population 2: * Diagnosis of breast cancer * Synchronous presence of a different tumor or chronic disease Population 3: \- Patients who are unfit for systemic chemotherapy treatment

Primary outcome measure(s)

EVs levels in early BC — 36 months
Determination of plasma EVs levels in patients with EBC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls
EVs levels in metastatic BC — 36 months
Determination of plasma EVs levels in patients with first diagnosis of metastatic BC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls

Trial sites (1)

Facility	City	Region	Status
Istituti Clinici Scientifici Maugeri SpA	Pavia	Lombardy	Recruiting

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Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting

The OPBC-07/microNAC Study Active, not recruiting

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting

Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting

Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05798338 on ClinicalTrials.gov ↗ ← All trials in Italy