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Trial Title:
Characterization of Extracellular Vesicles in Breast Cancer Patients
NCT ID:
NCT05798338
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Blood sample
Description:
Analysis of plasma in order to quantify and characterize EVs
Arm group label:
Early Breast Cancer patients
Arm group label:
Healthy patients
Arm group label:
Metastatic Breast Cancer patients
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Breast cancer patients
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Breast cancer is gender specific
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Istituti Clinici Scientifici Maugeri SpA
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Corsi, Professor
Phone:
0382592272
Email:
fabio.corsi@icsmaugeri.it
Contact backup:
Last name:
Sara Albasini, MsC
Phone:
3497378405
Email:
sara.albasini@icsmaugeri.it
Start date:
December 1, 2020
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Istituti Clinici Scientifici Maugeri SpA
Agency class:
Other
Source:
Istituti Clinici Scientifici Maugeri SpA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05798338
