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Clinical Trials in Italy / NCT06786663
Recruiting Observational

MALE Mamm Organoids

NCT06786663 · tracked via the Priya Life Science Italy tracker
Sponsor
Regina Elena Cancer Institute
Phase
Observational
Started
2024-04-19
Last updated
2025-01-22

Condition(s) studied

Breast Neoplasms, Male

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Tumor tissue samples collected — 36 months
    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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS National Cancer Institute "Regina Elena" Rome Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06786663 on ClinicalTrials.gov ↗ ← All trials in Italy