Analyzing extracellular vesicles in breast cancer patients
Characterization of Extracellular Vesicles in Breast Cancer Patients' Plasma by Single Molecule Detection Array (SiMoA) Digital ELISA
This study is testing if tiny particles in the blood from breast cancer patients can help us understand the disease better and see how it changes at different stages.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT05798338 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize and quantify tumor-derived extracellular vesicles (EVs) in breast cancer patients at different disease stages. It involves collecting blood samples from three groups: early breast cancer patients, healthy volunteers, and patients with metastatic breast cancer. The study will utilize a novel Single Molecule Array (SiMoA) technology to detect and quantify specific proteins associated with EVs, providing insights into their potential role as biomarkers. The research will follow Good Clinical Practice guidelines and is approved by the Ethical Committee of ICS Maugeri.
Who should consider this trial
Good fit: Ideal candidates include female patients diagnosed with early or metastatic breast cancer, as well as healthy female volunteers.
Not a fit: Patients with distant metastases or those unfit for systemic chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a minimally invasive liquid biopsy method for better prognostic and predictive assessment in breast cancer.
How similar studies have performed: Other studies have shown promise in using extracellular vesicles as biomarkers, but this specific approach utilizing SiMoA technology 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 Population 1: * Diagnosis of early breast cancer; * Indication for surgery after multidisciplinary discussion. Population 2: \- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment. Population 3: * Diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging; * Indication to chemotherapy. Exclusion Criteria: Population 1: * Presence of distant metastases * Synchronous presence of a different tumor * Indication to neoadjuvant chemotherapy Population 2: * Diagnosis of breast cancer * Synchronous presence of a different tumor or chronic disease Population 3: \- Patients who are unfit for systemic chemotherapy treatment
Where this trial is running
Pavia, Lombardy
- Istituti Clinici Scientifici Maugeri SpA — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Fabio Corsi, Professor
- Email: fabio.corsi@icsmaugeri.it
- Phone: 0382592272
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.