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Characterization of Extracellular Vesicles in Breast Cancer Patients

Recruitingn/aAges 18 Years - 90 YearsFemaleIstituti Clinici Scientifici Maugeri SpA
NCT05798338 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Blood sample
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Where

1 site
Istituti Clinici Scientifici Maugeri SpA
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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