MALE Mamm Organoids

Feasibility Study for the Generation of Organoids From Male Breast Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms, Male

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 Type: Observational
• Enrollment (Estimated): 7

Contacts and Locations

• Study Contact: Name: Giovanni Blandino, Medical Doctor; Phone Number: +39 +39 0652662911; Email: giovanni.blandino@ifo.it

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • IRCCS National Cancer Institute "Regina Elena"
    • Contact: Giovanni Blandino, Medical Doctor; Phone Number: +39 +39 0652662911; Email: giovanni.blandino@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male breast cancer (MBC)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor tissue samples collected	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.	36 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: S. Andrea Hospital; San Giovanni Addolorata Hospital; Weizmann Institute of Science, Israel

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): April 19, 2027

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Organoids
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Breast Neoplasms, Male
• Other Study ID Numbers: RS83/IRE/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No