Clinical trials / NCT05831397
Recruiting

Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy

Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from the 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 EVs may have a prognostic and predictive value in breast cancer. Considering their presence in body fluids and their minimally invasive assessment through blood sampling, EVs…

ClinicalTrials.gov IDNCT05831397
PhaseNot Applicable
Enrollment35
SponsorIstituti Clinici Scientifici Maugeri SpA
Age18 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 the 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 EVs may have a prognostic and predictive value in breast cancer. Considering their presence in body fluids and their minimally invasive assessment through blood sampling, EVs could be liquid biopsy-derived biomarkers. Their quantification could be a complex challenge, requiring complicated and time-consuming pre-analytical procedures of EVs isolation. A new method for the detection of tumor-derived-EVs associated proteins is 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 EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information about the efficacy of the neoadjuvant treatment.

Primary outcomes

Eligibility information

Inclusion Criteria: * Signing of a specific informed consent for participation to the study * Female sex BC patients: * Diagnosis of breast cancer * Any TNM stage * Indication to neoadjuvant chemotherapy after multidisciplinary discussion Healthy controls: • Patients with a negative mammography, breast ultrasound or clinical breast evaluation within 12 months of the study enrolment Exclusion Criteria: BC patients: • Indication to upfront surgery Healthy controls: • Diagnosis of breast cancer

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: 2026-09-28.