Actively Recruiting

Age: 18Years - 90Years
FEMALE
Healthy Volunteers
NCT05798338

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

Age: 18Years - 90Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy, 27100

Actively Recruiting

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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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