Characterization of Extracellular Vesicles in Breast Cancer Patients
Recruiting · NCT05798338 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Istituti Clinici Scientifici Maugeri SpA - Pavia, Lombardy, Italy