Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Breast cancer patients candidate for neoadjuvant chemotherapy
- description
- Female patients diagnosed with breast cancer, at any TNM stage, who are candidate to neoadjuvant treatment.
- label
- Healty control
- description
- Control group (sex and age matched): healthy volunteers, not affected by breast cancer (with negative mammography, breast ultrasound or breast examination within 12 months of the study enrolment).
Primary outcomes (2)
- measure
- EVs levels
- timeFrame
- 78 months
- description
- Measurement of plasma EVs levels (by Simoa-Elisa) in BC patients at the moment of diagnosis and comparison between EVs concentration in BC patients' and healthy controls.
- measure
- EVs levels in time
- timeFrame
- 78 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: BC patients: • Indication to upfront surgery Healthy controls: • Diagnosis of breast cancer
References
Publications (0)
Data not yet available