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Prospective Multicenter Study on the Collection of Tumor Biopsies and the Generation of Organoids Derived From Breast Cancer Patients Scheduled for Neoadjuvant Chemotherapy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
View:

• Female subjects;

• Confirmed diagnosis of breast heteroplasia

• Age 1\>= 8 years;

• Indication for neoadjuvant chemotherapy;

• 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.

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri
RECRUITING
Pavia
Contact Information
Primary
Fabio CorsI
fabio.corsi@icsmaugeri.it
+390382592272
Backup
Marta Truffi
marta.truffi@icsmaugeri.it
+390382592219
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2028-07
Participants
Target number of participants: 240
Related Therapeutic Areas
Sponsors
Collaborators: Buzzi Children's Hospital, The National Research Council, Italy, Università degli Studi di Brescia, ASST Fatebenefratelli Sacco
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov