Characterization of Extracellular Vesicles in Breast Cancer Patients

NCT05798338 | Recruiting

• 1 other identifier: 2490
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• EVs levels in early BC

  Determination of plasma EVs levels in patients with EBC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls

  36 months

• EVs levels in metastatic BC

  Determination of plasma EVs levels in patients with first diagnosis of metastatic BC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls

  36 months

Secondary Outcomes (2)

• EVs levels after surgery

  36 months

• EVs levels after chemotherapy treatment

  36 months

Study Arms (3)

Early Breast Cancer patients

* Diagnosis of early breast cancer; * Indication for surgery after multidisciplinary discussion.

Diagnostic Test: Blood sample

Metastatic Breast Cancer patients

* First diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging; * Indication to chemotherapy.

Diagnostic Test: Blood sample

Healthy patients

\- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment.

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Analysis of plasma in order to quantify and characterize EVs

Early Breast Cancer patients; Healthy patients; Metastatic Breast Cancer patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Breast cancer is gender specific
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients

You may qualify if:

• Signing of a specific informed consent for participation to the study
• Female sex
• Population 1:
• Diagnosis of early breast cancer;
• Indication for surgery after multidisciplinary discussion.
• Population 2:
• \- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment.
• Population 3:
• Diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging;
• Indication to chemotherapy.

You may not qualify if:

• Population 1:
• Presence of distant metastases
• Synchronous presence of a different tumor
• Indication to neoadjuvant chemotherapy
• Population 2:
• Diagnosis of breast cancer
• Synchronous presence of a different tumor or chronic disease
• Population 3:
• \- Patients who are unfit for systemic chemotherapy treatment

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

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Fabio Corsi, Professor

CONTACT

0382592272; fabio.corsi@icsmaugeri.it

SARA PAOLA ALBASINI, MsC

CONTACT

3497378405; 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: Prof

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: December 1, 2020
• Primary Completion: September 30, 2023
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)