Actively Recruiting
Feasibility Study to Create Organoids From Male Breast Tumors to Support Molecular Research and Personalized Treatment Development
Led by Regina Elena Cancer Institute · Updated on 2025-01-22
7
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
S
San Giovanni Addolorata Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the use of organoids derived from male breast tumors to better understand the molecular mechanisms that cause these tumors. This study aims to develop preclinical models that could help identify personalized and targeted treatments for male breast cancer. The project focuses on establishing at least five organoid cultures from male breast cancer patients who have undergone surgery. Scientists will assess how often these organoids can be successfully created and will compare the organoids to the original tumor tissues using comprehensive molecular analyses, including DNA mutation testing, gene expression profiling, and proteomic and metabolomic studies. Additionally, they will test the organoids' response to the same drugs given to the patients to evaluate functional similarity. Participants will provide tumor tissue samples during their surgery, which will be used to create and study the organoids over a 36-month period. The research team will collect and analyze these samples to measure molecular characteristics and drug responses. This long-term study is designed to improve understanding of male breast cancer and support the development of individualized therapies.
CONDITIONS
Official Title
MALE Mamm Organoids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 available for analyses
- Signing of the relevant informed consent form
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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Trial Site Locations
Total: 1 location
1
IRCCS National Cancer Institute "Regina Elena"
Rome, Italy, 00144
Actively Recruiting
Research Team
G
Giovanni Blandino, Medical Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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