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Life sciences · Observational Study
ClinicalTrials.gov · November 3, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT05798338). This is a study registration, not published results. Lead sponsor: Istituti Clinici Scientifici Maugeri SpA. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 105 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DIAGNOSTIC_TEST: Blood sample. Primary outcome measures: EVs levels in early BC , 36 months; EVs levels in metastatic BC , 36 months. Brief 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.