Analyzing extracellular vesicles in breast cancer patients

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Istituti Clinici Scientifici Maugeri SpA
  Pavia, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Fabio Corsi, Professor
• Email: fabio.corsi@icsmaugeri.it
• Phone: 0382592272

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.