MALE Mamm Organoids
ConditionBreast Neoplasms, Male
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorRegina Elena Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Male breast cancer (MBC)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
36 monthsSponsors and contacts
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Regina Elena Cancer Institute
Lead sponsor
San Giovanni Addolorata Hospital
Collaborator
Weizmann Institute of Science, Israel
Collaborator
S. Andrea Hospital
Collaborator
Source ClinicalTrials.gov