Characterization of Extracellular Vesicles in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Characterization of Extracellular Vesicles in Breast Cancer Patients' Plasma by Single Molecule Detection Array (SiMoA) Digital ELISA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798338
• Other study ID #: 2490
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Fabio Corsi, Professor
• Phone: 0382592272
• Email: fabio.corsi[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective, observational, monocentric and no profit study. The study involves the analysis of plasma from patients with breast cancer in order to quantify and characterize tumor-derived EVs at specific disease stages. The enrollment of consecutive patients affected by BC referring to an EUSOMA-accredited Breast Unit is planned. The patients will be divided into three pre-planned groups, as follows: Population 1: patients diagnosed with early breast cancer patients (stage I-III) with indication to curative surgery. Population 2: a control group made of sex- and age-matched healthy volunteers, not affected by cancer or chronic diseases. Population 3: patients with metastatic breast cancer diagnosis. For each patient a blood sample will be collected and plasma will be isolated. A new SiMoA assay based on the use of anti-CD63 and anti-CD9 antibodies, two well known protein markers of EVs, will be used to capture and quantify EVs directly from plasma without requiring any prior sample processing. The study will be conducted following the International Conference on Harmonization [ICH] Good Clinical Practice [GCP] guidelines. The Ethical Committee of ICS Maugeri authorized the study as protocol 2490/2020.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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. Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Blood sample
Analysis of plasma in order to quantify and characterize EVs

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri SpA	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	EVs levels after surgery	Determination of plasma EVs levels in patients with early BC one month after surgery and comparison with pre-surgery EVs levels in order to evaluate any qualitative of quantitative modifications in circulating EVs	36 months
Secondary	EVs levels after chemotherapy treatment	Determination of plasma EVs levels in patients with first diagnosis of metastatic BC after 4 months of systemic therapy and comparison with pre-therapy EV's plasma levels	36 months