Active — Not RecruitingNot Applicable

A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial

Italy3 participantsStarted 2024-10-10

Plain-language 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 model. If efficacy and tolerability are confirmed in vivo, this bioprosthetic model might be used to replace hormones' production in BRCA mutated patients undergoing prophylactic surgery.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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Inclusion Criteria: * 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 Criteria: * Other malignancies; * Final histological examination reporting malignant disease (any); * Desire of fertility sparing.

What they're measuring

oestrogens and progesterone's levels

Timeframe: minumum 3 months

Trial details

NCT IDNCT06497270

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

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