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Clinical Trials in Italy / NCT07421479
Active, not recruiting Observational

Patient-Derived Breast Cancer Organoids for Therapeutic Extracellular Vesicle Isolation (PDO-Mercurial01)

NCT07421479 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Phase
Observational
Started
2025-01-01
Last updated
2026-02-19

Condition(s) studied

Invasive Breast Cancer

Investigational drug(s) / intervention(s)

Blood and tumor tissue collection

Blood and tumor tissue collection: This prospective multicenter and observational study aims to recruit breast cancer patients who are candidates for surgery.After obtaining written and verbal informed consent, the following clinical and anamnestic data will be prospectively collected for each patient: age, comorbidities, type of breast lesion, lesion size assessed by imaging and post-operative histopathology, histological type, TNM disease stage, tumor grade, and biomolecular profile. In addition, follow-up data will be collected for each patient, including type of surgical procedure, type of treatment, and final histological report. Follow-up will extend for five years after surgery and will include information on any disease recurrence and subsequent treatments. rganoid cultures will be generated from surgical specimens to isolate extracellular vesicles (EVs) and evaluate their potential as delivery systems for indocyanine green in fluorescence-guided surgery.

Study summary

The aim of this study is to establish organoid cultures, which are three-dimensional in vitro tumor models capable of supporting the long-term ex vivo growth of tumor cells derived from patients with breast carcinoma. These organoids will be used for the isolation of extracellular vesicles (EVs), which are naturally released by cells and have the ability to selectively recognize tumor tissue. Due to these properties, EVs represent promising vectors for the targeted delivery of diagnostic agents, with potential applications in fluorescence-guided surgery.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female subjects; * Confirmed diagnosis of breast heteroplasia * Age \>= 18 years; * Patients willing to follow the usual oncological follow-up; * Patients with de novo metastatic disease (M+), receiving primary chemotherapy, if candidates for primary tumor biopsy; * Subjects who agree to participate in the study by signing and dating the Informed Consent form. Exclusion Criteria: * Patients without a proven cyto-histological diagnosis of breast carcinoma; * Subjects affected by other solid tumors besides the breast lesion.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istituti Clinici Scientifici Maugeri Pavia Italy

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07421479 on ClinicalTrials.gov ↗ ← All trials in Italy