Characterization of Extracellular Vesicles in Breast Cancer Patients

This is a prospective, observational, monocentric and no profit study. The study involves the analysis of plasma from patients with breast cancer in order to quantify and characterize tumor-derived EVs at specific disease stages. The enrollment of consecutive patients affected by BC referring to an EUSOMA-accredited Breast Unit is planned. The patients will be divided into three pre-planned groups, as follows: Population 1: patients diagnosed with early breast cancer patients (stage I-III) with indication to curative surgery. Population 2: a control group made of sex- and age-matched healthy volunteers, not affected by cancer or chronic diseases. Population 3: patients with metastatic breast cancer diagnosis. For each patient a blood sample will be collected and plasma will be isolated. A new SiMoA assay based on the use of anti-CD63 and anti-CD9 antibodies, two well known protein markers of EVs, will be used to capture and quantify EVs directly from plasma without requiring any prior sample processing. The study will be conducted following the International Conference on Harmonization \[ICH\] Good Clinical Practice \[GCP\] guidelines. The Ethical Committee of ICS Maugeri authorized the study as protocol 2490/2020.