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ACTIVE NOT RECRUITING
NCT06497270
NA

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2024-10-10

Completion Date

2027-06-01

Last Updated

2024-10-23

Healthy Volunteers

No

Interventions

PROCEDURE

Theca and Granulosa Cell Isolation

These patients will receive standard procedure during the risk reducing surgery but their ovaries will be used to extract theca and granulosa cells which will be used for the 3D bioprinted device's realisation.

Locations (1)

Day Hospital Tumori Femminili, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS

Rome, Italy