RecruitingNCT05831397

Extracellular Vesicles in Breast Cancer Patientsin Undergone Neoadjuvant Chemotherapy

Extracellular Vesicles as a Diagnostic and Prognostic Biomarker of Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients.


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

35 participants

Start Date

May 11, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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

Exclusion Criteria4

  • BC patients:
  • • Indication to upfront surgery
  • Healthy controls:
  • • Diagnosis of breast cancer

Locations(1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy

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