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Patient-Derived Breast Cancer Organoids for Therapeutic Extracellular Vesicle Isolation (PDO-Mercurial01)
Sponsor: Istituti Clinici Scientifici Maugeri SpA
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.
Official title: Prospective Single-center Study for the Generation of Organoids From Patients With Breast Carcinoma for Use in Extracellular Vesicle Isolation
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-01-01
Completion Date
2027-10-28
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Istituti Clinici Scientifici Maugeri
Pavia, Italy