Clinical trial · Interventional
A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial
NCT06497270CI-TRIAL-00081855DISC-OVARYactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA Mutation | — | UNRESOLVED | — |
| Estrogen Deficiency | — | UNRESOLVED | — |
| Menopause, Premature | — | UNRESOLVED | — |
| Menopause Related Conditions | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Surgical Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Theca and Granulosa Cell Isolation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BRCAmut patients
- description
- germinal BRCA1/2 mutated (BRCAmut) patients undergoing risk reducing salpingo-oophorectomy whose ovaries will be used to select theca and granulosa cells for the 3D bioprinted device.
- interventionNames
- Procedure: Theca and Granulosa Cell Isolation
Primary outcomes (1)
- measure
- oestrogens and progesterone's levels
- timeFrame
- minumum 3 months
- description
- (Unit: pg/mL for both hormones)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (21)
- BACKGROUNDAntoniou A, Pharoah PD, Narod S, Risch HA, Eyfjord JE, Hopper JL, Loman N, Olsson H, Johannsson O, Borg A, Pasini B, Radice P, Manoukian S, Eccles DM, Tang N, Olah E, Anton-Culver H, Warner E, Lubinski J, Gronwald J, Gorski B, Tulinius H, Thorlacius S, Eerola H, Nevanlinna H, Syrjakoski K, Kallioniemi OP, Thompson D, Evans C, Peto J, Lalloo F, Evans DG, Easton DF. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case Series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet. 2003 May;72(5):1117-30. doi: 10.1086/375033. Epub 2003 Apr 3. PMID 12677558
- BACKGROUNDGabaldo Barrios X, Sarabia Meseguer MD, Marin Vera M, Sanchez Bermudez AI, Macias Cerrolaza JA, Sanchez Henarejos P, Zafra Poves M, Garcia Hernandez MR, Cuevas Tortosa E, Aliaga Bano A, Castillo Guardiola V, Martinez Hernandez P, Tovar Zapata I, Martinez Barba E, Ayala de la Pena F, Alonso Romero JL, Noguera Velasco JA, Ruiz Espejo F. Molecular characterization and clinical interpretation of BRCA1/BRCA2 variants in families from Murcia (south-eastern Spain) with hereditary breast and ovarian cancer: clinical-pathological features in BRCA carriers and non-carriers. Fam Cancer. 2017 Oct;16(4):477-489. doi: 10.1007/s10689-017-9985-x. PMID 28477318
- BACKGROUNDMarchetti C, De Felice F, Palaia I, Perniola G, Musella A, Musio D, Muzii L, Tombolini V, Panici PB. Risk-reducing salpingo-oophorectomy: a meta-analysis on impact on ovarian cancer risk and all cause mortality in BRCA 1 and BRCA 2 mutation carriers. BMC Womens Health. 2014 Dec 12;14:150. doi: 10.1186/s12905-014-0150-5. PMID 25494812
- BACKGROUNDRocca WA, Grossardt BR, de Andrade M, Malkasian GD, Melton LJ 3rd. Survival patterns after oophorectomy in premenopausal women: a population-based cohort study. Lancet Oncol. 2006 Oct;7(10):821-8. doi: 10.1016/S1470-2045(06)70869-5. PMID 17012044
- BACKGROUNDMadalinska JB, Hollenstein J, Bleiker E, van Beurden M, Valdimarsdottir HB, Massuger LF, Gaarenstroom KN, Mourits MJ, Verheijen RH, van Dorst EB, van der Putten H, van der Velden K, Boonstra H, Aaronson NK. Quality-of-life effects of prophylactic salpingo-oophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. J Clin Oncol. 2005 Oct 1;23(28):6890-8. doi: 10.1200/JCO.2005.02.626. Epub 2005 Aug 29.