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TUBectomy with Delayed Oophorectomy for High-Risk Women

This study is looking at a new way to prevent ovarian cancer in women with certain genetic mutations, such as BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1. Instead of removing both the fallopian tubes and ovaries at the same time (risk-reducing salpingo-oophorectomy), this study tests removing only the fallopian tubes first (risk-reducing salpingectomy) and then removing the ovaries later (delayed oophorectomy). The goal is to see if this two-step approach is safe and effective in preventing high-grade serous (a type of ovarian) cancer. You may be eligible if you are a woman between 25 and 50 years old with one of these specific gene mutations and have completed childbearing. The study aims to enroll 3000 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific procedure. It plans to enroll 3000 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure high-grade serous ovarian cancer incidence until age 45 for BRCA1 carriers and age 50 for BRCA2 carriers.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04294927

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

Recruiting
NAAges 25–50InterventionalPrevention
University Medical Center Nijmegen
~3,000 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:Risk-reducing salpingectomy with delayed oophorectomyRisk-reducing salpingo-oophorectomy

At a glance

Recruiting sites
63 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
High grade serous (ovarian) cancer incidence
Measured over Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers

Conditions

BRCA1 Gene Mutation
BRCA2 Gene Mutation
RAD51C Gene Mutation
RAD51D Gene Mutation
BRIP1 Gene Mutation
Ovarian Cancer

Explore related trials

Malignant Ovarian NeoplasmBRCA1 GeneBRCA2 GeneBRIP1 GeneRAD51C GeneRAD51D Gene

Where it's being run

66 sites across 32 states
Netherlands11
Victoria4
Australia4
Germany4
Italy4
Poland4
Queensland3
Norway3

Study leadership

  • Joanne A. de Hullu, MD, PhD · PRINCIPAL_INVESTIGATOR · Radboud University Medical Center
  • Karen H. Lu, MD, PhD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
  • Rosella P.M.G. Hermens, MD,PhD · PRINCIPAL_INVESTIGATOR · Radboud University Medical Center
  • Elizabeth M. Swisher, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Joanne A. de Hullu, MD, PhD
[email protected]
+31 (0) 24 36 16683
Email the study team

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Eligibility criteria

Inclusion

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

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 this trial measures

  • High grade serous (ovarian) cancer incidenceUntil the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers

    High grade serous (ovarian) cancer incidence