TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

ID#: NCT04294927

Age: 25 - 50 years

Gender: Female

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: March 01, 2020

End Date: February 17, 2040

Contact Information:
Joanne A. de Hullu, MD, PhD
+31 (0) 24 36 16683
Karen H. Lu, MD, PhD
(713) 745-8902
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.
Eligibility:

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