NCT06786663

MALE Mamm Organoids

Feasibility Study for the Generation of Organoids From Male Breast Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms, Male

Timeline

• Start date: 2024-04-19
• Primary completion: 2027-04-19
• Completion: 2027-04-19
• First posted: 2025-01-22
• Last updated: 2025-01-22

Locations

1 site across 1 country: Italy