Actively Recruiting
Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2025-05-20
35
Participants Needed
1
Research Sites
345 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Female sex
- Diagnosis of breast cancer
- Any TNM stage of breast cancer
- Planned neoadjuvant chemotherapy after multidisciplinary discussion
- Healthy controls must have a negative mammography, breast ultrasound, or clinical breast exam within 12 months before enrollment
You will not qualify if you...
- Breast cancer patients indicated for upfront surgery without neoadjuvant chemotherapy
- Healthy controls with a diagnosis of breast cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
F
Fabio S 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
2
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