Ovarian Cancer Clinical Trial
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
Summary
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
Full Description
The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk.
PRIMARY OBJECTIVE:
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:
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:
Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers
Eligibility Criteria
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
Childbearing completed or no longer requires fallopian tubes
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 clinicals signs, diagnosis or treatment for malignant disease
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There are 3 Locations for this study
Boston Massachusetts, 02215, United States More Info
Principal Investigator
Seattle Washington, 98195, United States More Info
Principal Investigator
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