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MALE Mamm Organoids

Feasibility Study for the Generation of Organoids From Male Breast Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06786663
Enrollment
7
Registered
2025-01-22
Start date
2024-04-19
Completion date
2027-04-19
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Male

Keywords

Organoids

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.

Interventions

None listed

Sponsors

San Giovanni Addolorata Hospital
CollaboratorOTHER
Weizmann Institute of Science, Israel
CollaboratorUNKNOWN
S. Andrea Hospital
CollaboratorOTHER
Regina Elena Cancer Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tumor tissue samples collected36 monthsSamples 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.

Countries

Italy

Contacts

Primary ContactGiovanni Blandino, Medical Doctor
giovanni.blandino@ifo.it+39 0652662911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026