MALE Mamm Organoids

Recruiting

• Conditions: Breast Neoplasms, Male

• Registration Number: NCT06786663
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

It is believed that the use of organoids derived from male breast tumors can be of fundamental support for the definition of the molecular mechanisms underlying the onset of the tumor. Furthermore, the development of such preclinical models could be of significant support for the identification of specific personalized and ad hoc therapeutic treatments for male pathology.

Detailed Description

The main objective of the project is to set up at least 5 organoid cultures of male breast cancer derived from patients who have undergone surgery. This study will allow to define the success rate in the generation of organoids.

A secondary objective is to verify the correspondence between the organoids generated and the tumor tissue of origin.

In this regard, broad-spectrum molecular investigations will be carried out, such as mutational analysis of DNA through Whole Exome Sequencing (WES), gene expression profiles through RNA sequencing (RNAseq) and small RNA sequencing, proteomic and metabolomic analysis of both the tumors of origin and the cultures of derived organoids (PDO).

Furthermore, to verify the functional correspondence of the organoids with the tumor of origin, in vitro viability tests will be carried out by treating the PDOs with the same drugs administered to the patients.

Study Timeline

• Study Start: 2024-04-19
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2027-04-19
• Study Completion: 2027-04-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

• Men aged >18 years
• Patients with histologically confirmed breast cancer with or without synchronous metastases, who will undergo the relevant surgical intervention
• Adequate biological material to be able to carry out the analyses described above
• Signing of the relevant informed consent form

Exclusion Criteria

not present

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor tissue samples collected	36 months	Samples of tumor and peri-tumor tissue from the same patient, obtained at the time of surgery for the preparation of organoids to verify the functional correspondence of the organoid cultures obtained from the patients, with the tumors of origin. The organoids will be treated in vitro with doses equivalent to the plasma levels of the drugs administered to the patients, and the viability of the organoids will be assessed through ATPlite assays. Subsequently, the viability data will be compared with the response data of the patients.

Trial Locations

Locations (1)

IRCCS National Cancer Institute "Regina Elena"; 🇮🇹 Rome, Italy