Evaluating a new surgical 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 study aims to assess 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 gene mutations. The research will focus on whether delaying oophorectomy until the ages of 40-45 for BRCA1 and 45-50 for BRCA2 can maintain a similar level of protection against high-grade serous ovarian cancer compared to the current standard procedure. Participants will be premenopausal women who have completed childbearing and have at least one fallopian tube. The study will also evaluate the incidence of (pre)malignant findings and other related health outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2.

   * The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.
3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.
4. Presence of at least one fallopian tube.
5. Participants may have a personal history of non-ovarian malignancy.
6. Informed consent must be obtained and documented.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Postmenopausal status (natural menopause or due to (cancer) treatment)

   * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
   * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.
2. Wish for second stage RRO within two years after RRS (if clear at enrollment)
3. Legally incapable
4. Prior bilateral salpingectomy
5. A personal history of ovarian, fallopian tube, or peritoneal cancer
6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• WU St Louis
  St Louis, Missouri, United States Recruiting
• Mount Sinai Health System
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Roni Wilke, MD — M.D. Anderson Cancer Center
• Study coordinator: Roni Wilke, MD
• Email: rnitecki@mdanderson.org
• Phone: (713) 822-4502

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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.