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Salpingectomy with Delayed Oophrectomy for the Prevention of Ovarian Cancer in Women with BRCA1/2 Germline Mutations
Trial Status: active
This clinical trial investigates if removing 1 or both fallopian tubes (a risk-reducing salpingectomy—RRS) with a delayed removal of 1 or both ovaries (risk-reducing oophorectomy—RRO) may help to lower the risk of ovarian cancer compared to the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy—RRSO). BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of each cell's genetic material. When either of these genes is mutated, or altered, such that its protein product is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to some types of cancer including ovarian cancer. Having an RRS with a delayed RRO may prevent premature (early) menopause in the short term and may lower the risk of heart disease, osteoporosis (loss of bone strength), and mental status problems in the long term. However, it is not known if RRS with a delayed RRO may prevent ovarian cancer as well as standard of care RRSO in women who are carriers of BRCA1/2 germline mutations.
Inclusion Criteria
Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C 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
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
Exclusion Criteria
Postmenopausal status (natural menopause or due to [cancer] treatment)
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 clinical signs, diagnosis or treatment for malignant disease. Aromatase inhibitors, tamoxifen, and selective estrogen receptor modulators (SERM) are allowed
Additional locations may be listed on ClinicalTrials.gov for NCT05287451.
I. To 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 in BRCA1/2 gene germline mutation carriers.
SECONDARY OBJECTIVE:
I. Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy.
EXPLORATORY OBJECTIVE:
I. Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP A: Participants undergo RRS followed by RRO at least 2 years apart.
GROUP B: Participants undergo RRSO per standard of care.
After completion of study, participants are followed up annually for up to 15 years.
