Breast CancerNCT05798338
Characterization of Extracellular Vesicles in Breast Cancer Patients
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood sample
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- Population 1:
- Presence of distant metastases
- Synchronous presence of a different tumor
- Indication to neoadjuvant chemotherapy
- Population 2:
- Diagnosis of breast cancer
Show all 9Show fewer
- Synchronous presence of a different tumor or chronic disease
- Population 3:
- Patients who are unfit for systemic chemotherapy treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, 27100
Fabio Corsi, Professor, 0382592272, fabio.corsi@icsmaugeri.it
Sara Albasini, MsC, 3497378405, sara.albasini@icsmaugeri.it
About this study
Official title: Characterization of Extracellular Vesicles in Breast Cancer Patients' Plasma by Single Molecule Detection Array (SiMoA) Digital ELISA
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Blood sample
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Analysis of plasma in order to quantify and characterize EVs
| Study group | Role | What they receive |
|---|---|---|
| Early Breast Cancer patients | * Diagnosis of early breast cancer;
* Indication for surgery after multidisciplinary discussion. Receives: 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. Receives: Diagnostic Test: Blood sample | |
| Healthy patients | - Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment. Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 36 months
Secondary outcomes (2)
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
Measured: 36 months
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Dec 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798338
- Sponsor's protocol ID
- 2490
- Status last verified
- May 2026
- First submitted
- 21 Mar 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Extracellular Vesicles in Breast Cancer Patients' Plasma by Single Molecule Detection Array (SiMoA) Digital ELISA
- ClinicalTrials.gov ID
- NCT05798338
- Acronym / sponsor ID
- 2490
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Breast Cancer patients | – | Diagnostic Test: Blood sample* Diagnosis of early breast cancer; * Indication for surgery after multidisciplinary discussion. |
| Metastatic Breast Cancer patients | – | Diagnostic Test: Blood sample* First diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging; * Indication to chemotherapy. |
| Healthy patients | – | Diagnostic Test: Blood sample- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients
Key inclusion criteria (10 listed)
- Signing of a specific informed consent for participation to the study
- Female sex
- Diagnosis of early breast cancer;
- Indication for surgery after multidisciplinary discussion.
- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment.
Key exclusion criteria (9 listed)
- Presence of distant metastases
- Synchronous presence of a different tumor
- Indication to neoadjuvant chemotherapy
- Diagnosis of breast cancer
- Synchronous presence of a different tumor or chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAnalysis of plasma in order to quantify and characterize EVs | Diagnostic test | Early Breast Cancer patients, Healthy patients, Metastatic Breast Cancer patients |
Primary outcome
EVs levels in early BC
Time frame: 36 months
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
EVs levels in metastatic BC
Time frame: 36 months
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
2 secondary outcomes
EVs levels after surgery
Time frame: 36 months
EVs levels after chemotherapy treatment
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Corsi, Professor (0382592272, fabio.corsi@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVs levels in early BC (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.