Status:
ACTIVE_NOT_RECRUITING
A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
BRCA Mutation
Estrogen Deficiency
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Selecting theca and granulosa cells from removed ovaries of BRCA1/2mut patients undergoing Risk-reducing salpingo-oophorectomy (RRSO) and developing a 3D bioprinted hormone-producing bioprosthetic mod...
Detailed Description
Background and Rationale Women carrying germline BReast CAncer gene (BRCA) 1/2 mutations have an increased lifetime risk of breast and ovarian cancers (72% and 44% for BRCA1 and 69% and 17% for BRCA2,...
Eligibility Criteria
Inclusion
- Women between 18-40 years old;
- BRCA1/2 germline mutations;
- Completed childbearing;
- Willing to undergo RRSO;
- Negative final histological examination;
- No previous breast cancer.
Exclusion
- Other malignancies;
- Final histological examination reporting malignant disease (any);
- Desire of fertility sparing.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06497270
Start Date
October 10 2024
End Date
June 1 2027
Last Update
October 23 2024
Active Locations (1)
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1
Day Hospital Tumori Femminili, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS
Rome, Italy, 00168