TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention (NCT04294927) | Clinical Trial Compass
RecruitingNot Applicable
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
United States3,000 participantsStarted 2020-03-01
Plain-language summary
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
Who can participate
Age range25 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
* Age at inclusion;
* BRCA1: 25-40 years
* BRCA2: 25-45 years
* RAD51C, RAD51D, BRIP1: 25-50 years
* Childbearing completed
* Presence of at least one fallopian tube
* Participants may have a personal history of non-ovarian malignancy
* Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.
Exclusion Criteria:
* Postmenopausal status (natural menopause or due to treatment)
* Wish for second stage RRO within two years after RRS
* Legally incapable
* Prior bilateral salpingectomy
* A personal history of ovarian, fallopian tube or peritoneal cancer
* Current diagnosis or treatment for malignant disease
What they're measuring
1
High grade serous (ovarian) cancer incidence
Timeframe: Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers