Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy

NCT05831397 | Recruiting

• 1 other identifier: 2540
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• EVs levels

  Measurement of plasma EVs levels (by Simoa-Elisa) in BC patients at the moment of diagnosis and comparison between EVs concentration in BC patients' and healthy controls.

  78 months

• EVs levels in time

  Evaluation of tumor-related EVs as predictive markers of neoadjuvant treatment efficacy in BC patients. This will be conducted comparing EVs level during different collected times

  78 months

Study Arms (2)

Breast cancer patients candidate for neoadjuvant chemotherapy

Female patients diagnosed with breast cancer, at any TNM stage, who are candidate to neoadjuvant treatment.

Healty control

Control group (sex and age matched): healthy volunteers, not affected by breast cancer (with negative mammography, breast ultrasound or breast examination within 12 months of the study enrolment).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Breast cancer is gender based
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Population 1: female patients diagnosed with breast cancer, at any TNM stage, who are candidate to neoadjuvant treatment. * Population 2: a control group of sex and age matched healthy volunteers, not affected by breast cancer (with negative mammography, breast ultrasound or clinical breast examination within 12 months of the study enrolment).

You may qualify if:

• Signing of a specific informed consent for participation to the study
• Female sex
• BC patients:
• Diagnosis of breast cancer
• Any TNM stage
• Indication to neoadjuvant chemotherapy after multidisciplinary discussion
• Healthy controls:
• Patients with a negative mammography, breast ultrasound or clinical breast evaluation within 12 months of the study enrolment

You may not qualify if:

• BC patients:
• Indication to upfront surgery
• Healthy controls:
• Diagnosis of breast cancer

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Fabio S Corsi, Professor

CONTACT

+390382592272; fabio.corsi@icsmaugeri.it

SARA PAOLA ALBASINI, MsC

CONTACT

+393497378405; sara.albasini@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: May 11, 2021
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 21, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

IT (1)