NCT05798338

Characterization of Extracellular Vesicles in Breast Cancer Patients

Recruiting now Last updated 25 November 2025

What this trial tests

trial testing Blood sample in Breast Cancer in 105 participants. Currently enrolling.

Timeline

1 December 2020

Primary endpoint
30 September 2023

30 September 2026

Quick facts

Lead sponsor	Istituti Clinici Scientifici Maugeri SpA
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	105
Start date	1 December 2020
Primary completion	30 September 2023
Estimated completion	30 September 2026
Sites	1 location across Italy

Drugs / interventions tested

• Blood sample — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

Adults 18 to 90, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pre-metastatic niche: formation, characteristics and therapeutic implication.
   Wang Y, Jia J, Wang F, Fang Y, et al · · 2024 · cited 143× · PMID 39317708 · DOI 10.1038/s41392-024-01937-7
2. Extracellular Vesicles for Clinical Diagnostics: From Bulk Measurements to Single-Vesicle Analysis.
   Tran HL, Zheng W, Issadore DA, Im H, et al · · 2025 · cited 25× · PMID 40720603 · DOI 10.1021/acsnano.5c00706
3. Influence of Extracellular Vesicles on Lung Stromal Cells during Breast Cancer Metastasis.
   Patel U, Susman D, Allan AL. · · 2023 · cited 13× · PMID 37511559 · DOI 10.3390/ijms241411801
4. Extracellular vesicles in age-related diseases: disease pathogenesis, intervention, and biomarker.
   Putri PHL, Alamudi SH, Dong X, Fu Y. · · 2025 · cited 10× · PMID 40437603 · DOI 10.1186/s13287-025-04374-7
5. Exosomes, their sources, and possible uses in cancer therapy in the era of personalized medicine.
   Zemanek T, Danisovic L, Nicodemou A. · · 2024 · cited 8× · PMID 39724442 · DOI 10.1007/s00432-024-06066-w
6. Comparison Study of Small Extracellular Vesicle Isolation Methods for Profiling Protein Biomarkers in Breast Cancer Liquid Biopsies.
   Lee Y, Ni J, Wasinger VC, Graham P, et al · · 2023 · cited 7× · PMID 37895140 · DOI 10.3390/ijms242015462
7. Hsp70 and Calcitonin Receptor Protein in Extracellular Vesicles from Glioblastoma Multiforme: Biomarkers with Putative Roles in Carcinogenesis and Potential for Differentiating Tumor Types.
   Alberti G, Sánchez-López CM, Marcilla A, Barone R, et al · · 2024 · cited 6× · PMID 38542389 · DOI 10.3390/ijms25063415
8. Extracellular Vesicles in cancer: from isolation and characterization to metastasis, drug resistance, and clinical applications.
   Jurj A, Paul D, Calin GA. · · 2025 · cited 4× · PMID 40629268 · DOI 10.1186/s12885-025-14375-7