Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy
Recruiting now
Conditions studied: Breast Cancer
In brief
Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from the 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 EVs may have a prognostic and predictive value in breast cancer. Considering their presence in body fluids and their minimally invasive assessment through blood sampling, EVs could be liquid biopsy-derived biomarkers. Their quantification could be a complex challenge, requiring complicated and time-consuming pre-analytical procedures of EVs isolation. A new method for the detection of tumor-derived-EVs associated proteins is 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 EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information about the efficacy of the neoadjuvant treatment.
Key facts
- Study ID
- NCT05831397
- Run by
- Istituti Clinici Scientifici Maugeri SpA
- People needed
- 35
- Starts
- 2021-05-11
- Expected to finish
- 2027-12-21
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Signing of a specific informed consent for participation to the study
- Female sex
- BC patients:
- Diagnosis of breast cancer
- Any TNM stage
- Indication to neoadjuvant chemotherapy after multidisciplinary discussion
- Healthy controls:
- Patients with a negative mammography, breast ultrasound or clinical breast evaluation within 12 months of the study enrolment
You may not qualify if…
- BC patients:
- Indication to upfront surgery
- Healthy controls:
- Diagnosis of breast cancer
Where it is running
- Istituti Clinici Scientifici Maugeri SpA — Pavia, Lombardy, Italy (enrolling)
Full record on ClinicalTrials.gov
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