MALE Mamm Organoids
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Male. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility Study for the Generation of Organoids From Male Breast Tumors
Overview
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.
Primary outcome measures
- Tumor tissue samples collected [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- IRCCS National Cancer Institute "Regina Elena" — Rome
Identifiers
NCT: NCT06786663 · RS83/IRE/23