Creating organoid cultures from male breast tumors
Feasibility Study for the Generation of Organoids From Male Breast Tumors
This study is trying to grow mini versions of male breast tumors from patients to see how well they match the original tumors and how they respond to treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06786663 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish organoid cultures derived from male breast cancer patients who have undergone surgery. The project will generate at least five organoid cultures to assess their success rate and verify their correspondence with the original tumor tissue. Comprehensive molecular investigations, including DNA mutational analysis, RNA sequencing, and proteomic studies, will be conducted to understand the underlying mechanisms of the tumor. Additionally, in vitro viability tests will evaluate the organoids' response to the same treatments given to the patients.
Who should consider this trial
Good fit: Ideal candidates include men over 18 years with histologically confirmed breast cancer who are scheduled for surgical intervention.
Not a fit: Patients without adequate biological material for analysis or those not undergoing surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized therapeutic strategies for male breast cancer patients.
How similar studies have performed: While organoid technology is gaining traction, this specific focus on male breast cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome
- IRCCS National Cancer Institute "Regina Elena" — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Blandino, Medical Doctor
- Email: giovanni.blandino@ifo.it
- Phone: +39 0652662911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.