Analyzing extracellular vesicles in breast cancer patients undergoing chemotherapy
Extracellular Vesicles as a Diagnostic and Prognostic Biomarker of Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients.
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 |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT05831397 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients diagnosed with breast cancer at any TNM stage who are indicated for neoadjuvant chemotherapy.
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.
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 performed: Other studies have shown promise in using extracellular vesicles as biomarkers in cancer, but this specific approach with SiMoA is relatively novel.
Eligibility criteria
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 this trial is running
Pavia, Lombardy
- Istituti Clinici Scientifici Maugeri SpA — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Fabio S Corsi, Professor
- Email: fabio.corsi@icsmaugeri.it
- Phone: +390382592272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.