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 now · Not applicable

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer

In brief

This is a prospective preference study that will evaluate 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

Key facts

Study ID

NCT05287451

Run by

M.D. Anderson Cancer Center

People needed

100

Starts

2022-05-10

Expected to finish

2026-12-26

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
• 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.
• No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.
• Presence of at least one fallopian tube.
• Participants may have a personal history of non-ovarian malignancy.
• Informed consent must be obtained and documented.

You may not qualify if…

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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.
• Wish for second stage RRO within two years after RRS (if clear at enrollment)
• Legally incapable
• Prior bilateral salpingectomy
• A personal history of ovarian, fallopian tube, or peritoneal cancer
• Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• WU St Louis — St Louis, Missouri, United States (enrolling)
• Mount Sinai Health System — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Lyndon Baines Johnson General — Houston, Texas, United States (enrolling)
• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.