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

NCT07421479 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-19

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-10-28
Completion
2027-10-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07421479 on ClinicalTrials.gov