MALE Mamm Organoids

NCT06786663 | Recruiting

• 1 other identifier: RS83/IRE/23
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms, Male

Keywords

Organoids

Outcome Measures

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.

  36 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male breast cancer (MBC)

You may qualify if:

• 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

You may not qualify if:

• not present

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• San Giovanni Addolorata Hospital: collaborator
• Weizmann Institute of Science, Israel: collaborator
• S. Andrea Hospital: collaborator

Study Sites (1)

IRCCS National Cancer Institute "Regina Elena"

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Organoids from male breast tumor tissue collected during surgery (according to standard clinical practice)

MeSH Terms

Conditions

Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Giovanni Blandino, Medical Doctor

CONTACT

+39 0652662911; giovanni.blandino@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: April 19, 2024
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): April 19, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)