Risk-Reducing Salpingectomy with Delayed Oophorectomy for Ovarian Cancer Prevention

This study is looking at a new way to prevent ovarian and fallopian tube cancer in women who have a high risk due to changes (mutations) in genes like BRCA1 or BRCA2. The study compares two procedures: the standard approach, called Risk-Reducing Salpingo-Oophorectomy (RRSO), which removes both the fallopian tubes and ovaries at the same time, and a new approach called Risk-Reducing Salpingectomy (RRS) with delayed Risk-Reducing Oophorectomy (RRO). This new approach removes the fallopian tubes first, and then the ovaries later. The goal is to see if the new approach is as effective as the standard one in preventing high-grade serous (a type of ovarian) cancer, while potentially delaying menopause. You may be able to join if you are a premenopausal woman with certain gene mutations and meet specific age requirements.

Study design
This is an interventional study planning to enroll 100 participants. It is a prospective preference study, meaning participants will choose between the two treatment options.
What's involved
You would complete questionnaires and have a standard-of-care laparoscopy (a surgical procedure to look inside the abdomen) before your assigned procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint will be measured through study completion, which is an average of 15 years.

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NCT05287451

Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study

Recruiting
NAAges 18+InterventionalPrevention
M.D. Anderson Cancer Center
~100 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:RIsk-Reducing Salpingectomy (RRS)Risk-Reducing Oophorectomy-RRORisk-Reducing Salpingo-Oophorectomy-RRSO

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.
Measured over through study completion, an average of 15 years
Ovarian Cancer
Fallopian Tube Cancer
9 sites across 7 states
New York2
Texas2
Massachusetts1
Minnesota1
Missouri1
Pennsylvania1
Washington1
  • Roni Wilke, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Eligibility criteria

Inclusion

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

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.
  • To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers.through study completion, an average of 15 years