Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers

Summary

The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

* Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
* Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
* Childbearing completed
* Presence of at least one fallopian tube
* Participants may have a personal history of non-ovarian malignancy

Exclusion Criteria:

* Postmenopausal status (natural menopause or due to (cancer) treatment)
* Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
* Legally incapable
* Prior bilateral salpingectomy
* A personal history of ovarian, fallopian tube or peritoneal cancer
* Evidence of malignant disease at enrollment
* Treatment for malignant disease at enrollment
* Inability to read or speak Dutch

BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need

Outcome Measures

Locations