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Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Summary
The aim of this study is to establish patient-derived organoid (PDO) and tumor tissue cultures from breast cancer patients, in order to create personalized, accurate, and reliable preclinical models capable of providing information on the diverse biomolecular portraits of breast cancer. These models may also be used to predict the achievement of pathological complete response after neoadjuvant chemotherapy (NAC) treatment, study the biological, molecular, genetic, and microenvironmental characteristics of each tumor, and isolate tumor-derived extracellular vesicles from the PDOs and tissues and analyze them as potential biomarkers of response to NAC.
Official title: Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
240
Start Date
2025-09-23
Completion Date
2028-07
Last Updated
2025-12-03
Healthy Volunteers
Not specified
Conditions
Interventions
Blood and tumor tissue collection
This prospective multicenter and observational study aims to recruit breast cancer patients scheduled for neoadjuvant chemotherapy (NAC). After obtaining informed consent, detailed clinical and anamnestic data will be collected, including tumor type and size, TNM stage, and biomolecular profile. During the clip placement procedure, which is performed before NAC to locate the lesion site, two tissue biopsies will be collected, processed, and used for PDO and tissue culture. The pre-NAC biopsy will utilize the clip needle, avoiding any additional discomfort. In cases of incomplete clinical response to NAC, a sample of residual neoplasia will also be collected from the surgical specimen after the operation, following the sampling for appropriate histopathological analyses. For each patient participating in the study, a blood sample is also planned to be collected at the following timepoints: T0, before the start of NAC; T1, mid-therapy; and T2, at the end of therapy before surgery.
Locations (1)
Istituti Clinici Scientifici Maugeri
Pavia, PV, Italy