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

NCT07421479 | Active Not Recruiting

• 1 other identifier: PDO-Mercurial 01 - CTSPV66-25
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Invasive Breast Cancer

Keywords

Triple Negative Breast Cancer; Patient-Derived Organoids; Extracellular Vesicles

Outcome Measures

Primary Outcomes (1)

• Establishment of Patient-Derived Organoids of Breast Cancer

  Number and proportion of patients from which Patient-Derived Organoids lines will be succesfully established from collected tumor tissue samples

  36 months

Interventions

Blood and tumor tissue collection PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients consecutively referred to the Breast Unit of the IRCCS ICS Maugeri in Pavia who have breast neoplasm will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• Patients without a proven cyto-histological diagnosis of breast carcinoma;
• Subjects affected by other solid tumors besides the breast lesion.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Pavia, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, plasma, organoids

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-01

Locations

IT (1)