Actively Recruiting
Characterization of Extracellular Vesicles in Breast Cancer Patients
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2025-11-25
105
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Characterization of Extracellular Vesicles in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent for study participation
- Female sex
- For early breast cancer group: diagnosis of early breast cancer and planned surgery
- For control group: negative mammography or breast ultrasound within 12 months
- For metastatic breast cancer group: confirmed metastatic breast cancer diagnosis and planned chemotherapy
You will not qualify if you...
- For early breast cancer group: presence of distant metastases
- For early breast cancer group: having another tumor at the same time
- For early breast cancer group: planned neoadjuvant chemotherapy
- For control group: diagnosis of breast cancer
- For control group: having another tumor or chronic disease
- For metastatic breast cancer group: unfit for systemic chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
F
Fabio Corsi, Professor
CONTACT
S
SARA PAOLA ALBASINI, MsC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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