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NCT Number: NCT06786663

MALE Mamm Organoids

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

IRCCS National Cancer Institute "Regina Elena"

Rome, 00144, Italy

Location status: Recruiting

Location contact

Giovanni Blandino, Medical Doctor

CONTACT

[email protected]

+39 0652662911 ext. +39

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tumor tissue samples collected

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Blandino, Medical Doctor

CONTACT

[email protected]

+39 0652662911 ext. +39

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

  • S. Andrea Hospital
  • San Giovanni Addolorata Hospital
  • Weizmann Institute of Science, Israel

Registry information

Official study title

Feasibility Study for the Generation of Organoids From Male Breast Tumors

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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