Delayed Oophorectomy for Women at High Risk of Ovarian Cancer

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

Recruiting N/A Interventional Study
BRCA1 Gene Mutation BRCA2 Gene Mutation RAD51C Gene Mutation RAD51D Gene Mutation BRIP1 Gene Mutation Ovarian Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
25 – 50
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
3,000 (estimated)
Sponsor
University Medical Center Nijmegen · Other
Who this trial is looking for

This trial is looking for women who have a specific gene mutation that increases their risk of ovarian cancer. Participants will undergo a procedure to remove their fallopian tubes and will have scheduled surgery to remove ovaries later.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a class 5 BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1 gene mutation.
  • I am between 25 and 40 years old if I have the BRCA1 mutation.
  • I am between 25 and 45 years old if I have the BRCA2 mutation.
  • I am between 25 and 50 years old if I have the RAD51C, RAD51D, or BRIP1 mutation.
  • I have completed my childbearing.
  • I still have at least one fallopian tube.
  • I can give informed consent for the study.

You may not be able to join if

  • I am postmenopausal.
  • I want a second surgery within two years after the first.
  • I am legally incapable of giving consent.
  • I have had a bilateral salpingectomy.
  • I have a history of ovarian, fallopian tube, or peritoneal cancer.
  • I currently have cancer or am undergoing treatment for cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 * Presen…
Contacts

Joanne A. de Hullu, MD, PhD

+31 (0) 24 36 16683

Joanne.deHullu@radboudumc.nl

CONTACT

Karen H. Lu, MD, PhD

(713) 745-8902

khlu@mdanderson.org

CONTACT