Characterization of Extracellular Vesicles in Breast Cancer Patients
NCT ID: NCT05798338
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
105 participants
OBSERVATIONAL
2020-12-01
2026-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Early Breast Cancer patients
* Diagnosis of early breast cancer;
* Indication for surgery after multidisciplinary discussion.
Blood sample
Analysis of plasma in order to quantify and characterize EVs
Metastatic Breast Cancer patients
* First diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging;
* Indication to chemotherapy.
Blood sample
Analysis of plasma in order to quantify and characterize EVs
Healthy patients
\- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment.
Blood sample
Analysis of plasma in order to quantify and characterize EVs
Interventions
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Blood sample
Analysis of plasma in order to quantify and characterize EVs
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
FEMALE
Yes
Sponsors
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Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
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Fabio Corsi
Prof
Locations
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Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2490
Identifier Type: -
Identifier Source: org_study_id
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