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Clinical Trials in Italy / NCT06497270
Active, not recruiting Not applicable

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

NCT06497270 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Not applicable
Started
2024-10-10
Last updated
2024-10-23

Condition(s) studied

BRCA MutationEstrogen DeficiencySurgical MenopauseMenopause Related ConditionsMenopause, PrematureOvarian Cancer

Investigational drug(s) / intervention(s)

Theca and Granulosa Cell Isolation

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • oestrogens and progesterone's levels — minumum 3 months
    (Unit: pg/mL for both hormones)

Trial sites (1)

FacilityCityRegionStatus
Day Hospital Tumori Femminili, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS Rome Italy

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Other trials for the same condition

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) Recruiting
Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers Recruiting
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) Recruiting
Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery Active, not recruiting
Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06497270 on ClinicalTrials.gov ↗ ← All trials in Italy