Analyzing extracellular vesicles in breast cancer patients undergoing chemotherapy
Official title: Extracellular Vesicles as a Diagnostic and Prognostic Biomarker of Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients.
Run by Istituti Clinici Scientifici Maugeri SpA · NCT05831397 · Data updated 2026-11-12
This study is trying to see if tiny particles from tumors in breast cancer patients getting chemotherapy can help doctors understand how well the treatment is working compared to healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 35 (estimated) |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | May 11, 2021 |
| Main results expected | December 21, 2027 |
| Study ends | December 21, 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT05831397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients diagnosed with breast cancer at any TNM stage who are indicated for neoadjuvant chemotherapy.
✕Probably not a fit
Patients who are indicated for upfront surgery or those with a diagnosis of breast cancer in the control group will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the presence and characteristics of tumor-derived extracellular vesicles (EVs) in breast cancer patients receiving neoadjuvant chemotherapy. It involves collecting plasma samples from participants at various stages of treatment to quantify EVs using a novel detection method called Single Molecule Array (SiMoA). The study will include both breast cancer patients and a control group of healthy volunteers to compare the findings. The goal is to assess the potential of EVs as biomarkers for treatment efficacy and disease progression.
Why it matters
Potential benefit: If successful, this study could provide a minimally invasive method for monitoring treatment response in breast cancer patients.
How similar studies have gone: Other studies have shown promise in using extracellular vesicles as biomarkers in cancer, but this specific approach with SiMoA is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Fabio S Corsi, Professor
- Email: fabio.corsi@icsmaugeri.it
- Phone: +390382592272
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.