Clinical trials / NCT05798338
Recruiting

Characterization of Extracellular Vesicles in Breast Cancer Patients

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…

ClinicalTrials.gov IDNCT05798338
PhaseNot Applicable
Enrollment105
SponsorIstituti Clinici Scientifici Maugeri SpA
Age18 Years – 90 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.