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

Recruiting now · Not applicable

Conditions studied: BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation, BRIP1 Gene Mutation, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT04294927

Run by

University Medical Center Nijmegen

People needed

3000

Starts

2020-03-01

Expected to finish

2040-02-17

Last updated by the study team

2026-04-06

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University Medical Center — St Louis, Missouri, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Harris Health Lyndon B. Johnson Hospital — Houston, Texas, United States (enrolling)
• MD Anderson Cancer Centre — Houston, Texas, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Chris O'Brien Lifehouse — Sydney, New South Wales, Australia (enrolling)
• Westmead hospital — Sydney, New South Wales, Australia (enrolling)
• St Andrew War Memorial Hospital — Brisbane, Queensland, Australia (enrolling)
• Royal Brisbane Hospital — Brisbane, Queensland, Australia (enrolling)
• Greenslopes Private Hospital — Brisbane, Queensland, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• Frances Perry House — Melbourne, Victoria, Australia (enrolling)
• Mercy Hospital — Melbourne, Victoria, Australia (enrolling)
• Epworth Hospital — Richmon, Victoria, Australia (enrolling)
• Western Health — St Albans, Victoria, Australia (enrolling)
• King Edward Memorial Hospital — Perth, Western Australia, Australia (enrolling)
• The Mater Hospital — Brisbane, Australia (enrolling)
• Monash Health — Melbourne, Australia (enrolling)
• Peter MacCallum Centre — Melbourne, Australia (enrolling)
• UChicago Medicine — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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