Health TrialsbyHealthPanel

Characterization of Extracellular Vesicles in Breast Cancer Patients

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-90
SponsorIstituti Clinici Scientifici Maugeri SpA

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signing of a specific informed consent for participation to the study

Female sex

Diagnosis of early breast cancer;

Indication for surgery after multidisciplinary discussion.

Disqualifiers

Presence of distant metastases

Synchronous presence of a different tumor

Indication to neoadjuvant chemotherapy

Diagnosis of breast cancer

Trial population

Breast cancer patients

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Diagnostic test

    Analysis of plasma in order to quantify and characterize EVs

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Early Breast Cancer patients1 intervention
Group B: Metastatic Breast Cancer patients1 intervention
Group C: Healthy patients1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
36 months
2

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

Time frame
36 months

Secondary outcomes

1

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

Time frame
36 months
2

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

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituti Clinici Scientifici Maugeri SpA

Lead sponsor

Source ClinicalTrials.gov
Apply now