Actively Recruiting

Age: 18Years - 80Years
FEMALE
NCT05831397

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

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy, 27100

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here