Assessing a new approach to reduce ovarian cancer risk in high-risk women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the safety and effectiveness of risk-reducing salpingectomy with delayed oophorectomy as an alternative to the standard risk-reducing salpingo-oophorectomy in women with BRCA1/2 and other gene mutations. The study aims to determine the long-term effects of this innovative strategy on ovarian cancer incidence, given the high mortality rates associated with ovarian cancer and the limitations of current surveillance methods. Participants will undergo a surgical procedure to remove the fallopian tubes, with oophorectomy performed at a later date, allowing for a potential reduction in cancer risk while minimizing immediate menopause-related complications.

Why it matters

Who can join: the full rules

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

Where it's running

• UChicago Medicine
  Chicago, Illinois, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Washington University Medical Center
  St Louis, Missouri, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

+16 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Joanne A. de Hullu, MD, PhD — Radboud University Medical Center
• Study coordinator: Joanne A. de Hullu, MD, PhD
• Email: Joanne.deHullu@radboudumc.nl
• Phone: +31 (0) 24 36 16683

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.