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

NCT06497270Active, Not RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

3

Start Date

2024-10-10

Completion Date

2026-06-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Theca and Granulosa Cell Isolation

Conditions

BRCA MutationEstrogen DeficiencySurgical MenopauseMenopause Related ConditionsMenopausePrematureOvarian Cancer

Eligibility

Age Range

18 Years – 40 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

oestrogens and progesterone's levels

(Unit: pg/mL for both hormones)

Time frame: minumum 3 months

Locations

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

Linked Papers

2020-08-16

Attitudes towards risk‐reducing early salpingectomy with delayed oophorectomy for ovarian cancer prevention: a cohort study

ObjectiveTo determine risk‐reducing early salpingectomy and delayed oophorectomy (RRESDO) acceptability and effect of surgical prevention on menopausal sequelae/satisfaction/regret in women at increased ovarian cancer (OC) risk.DesignMulticentre, cohort, questionnaire study (IRSCTN:12310993).SettingUnited Kingdom (UK).PopulationUK women without OC ≥18 years, at increased OC risk, with/without previous RRSO, ascertained through specialist familial cancer/genetic clinics and BRCA support groups.MethodsParticipants completed a 39‐item questionnaire. Baseline characteristics were described using descriptive statistics. Logistic/linear regression models analysed the impact of variables on RRESDO acceptability and health outcomes.Main outcomesRRESDO acceptability, menopausal sequelae, satisfaction/regret.ResultsIn all, 346 of 683 participants underwent risk‐reducing salpingo‐oophorectomy (RRSO). Of premenopausal women who had not undergone RRSO, 69.1% (181/262) found it acceptable to participate in a research study offering RRESDO. Premenopausal women concerned about sexual dysfunction were more likely to find RRESDO acceptable (odds ratio [OR] = 2.9, 95% CI 1.2–7.7, P = 0.025). Women experiencing sexual dysfunction after premenopausal RRSO were more likely to find RRESDO acceptable in retrospect (OR = 5.3, 95% CI 1.2–27.5, P < 0.031). In all, 88.8% (143/161) premenopausal and 95.2% (80/84) postmenopausal women who underwent RRSO, respectively, were satisfied with their decision, whereas 9.4% (15/160) premenopausal and 1.2% (1/81) postmenopausal women who underwent RRSO regretted their decision. HRT uptake in premenopausal individuals without breast cancer (BC) was 74.1% (80/108). HRT use did not significantly affect satisfaction/regret levels but did reduce symptoms of vaginal dryness (OR = 0.4, 95% CI 0.2–0.9, P = 0.025).ConclusionData show high RRESDO acceptability, particularly in women concerned about sexual dysfunction. Although RRSO satisfaction remains high, regret rates are much higher for premenopausal women than for postmenopausal women. HRT use following premenopausal RRSO does not increase satisfaction but does reduce vaginal dryness.Tweetable abstractRRESDO has high acceptability among premenopausal women at increased ovarian cancer risk, particularly those concerned about sexual dysfunction.

Linked Investigators

Ranjit Manchanda

Ranjit Manchanda is a Professor at Wolfson Institute of Preventive Medicine, Barts CRUK Cancer Centre, QMUL, and Consultant Gynaecological Oncologist at Barts and the Royal London Hospital, London, UK. Ranjit’s research interests are focused around Targeted Precision Prevention. This includes population-based germline testing, mainstreaming genetic testing and precision medicine approaches for risk prediction, stratification, and targeted screening & cancer prevention. He has a keen research interest in health economic issues related to his areas of research. He is the Principal Investigator on the PROTECTOR trial, PROMISE Pilot study, GCaPPS trial, RRESDO, SIGNPOST, DETECT and UKCOGS studies. He was awarded an NHS Innovation Accelerator (NIA) Fellowship for Population Genetic Testing (2019). He is a recipient of the RCOG Blair Bell award (2018) for research in population testing and the Dr Shyam Agarwal Memorial Oration award (2019) for contribution to cancer genetics. He has also received the Helen Harris Memorial Trust travelling Fellowship and NIHR Clinical Lecturer Fellowship awards. He is co-Lead for the Cancer Prevention Theme at the Barts CRUK Cancer Centre. He is the Specialty Research Lead for Gynaecological Cancer, NIHR North Thames Clinical Research Network (CRN). He leads the high-risk women’s Precision Prevention Clinic at Barts Health and is chair of the London Cancer High risk Gynaecological Cancer MDT. He is a member of the NCRI Ovarian Cancer Surgical Sub group and has a keen interest in ultra-radical debulking surgery for ovarian cancer. He is a member of number of other advisory bodies and oversight committees. He is the Integrated Academic Training Programme Director, London Specialty School of Obstetrics & Gynaecology, Health Education England, & Lead for the RCOG Advanced Professional Module (APM) in Clinical Research for London. He is a member of number of committees related to research and training. He has led a number of training initiatives in Gynaecological Oncology across Europe. He has served as President of the European Network of Young Gynaecological Oncologists (ENYGO) and member of the European Society of Gynaecological Oncology (ESGO) Council from 2011-2013.

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