Brief Title
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
Official Title
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
Brief 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
Detailed 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
Study Type
Interventional
Primary Outcome
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.
Condition
Ovarian Cancer
Intervention
RIsk-Reducing Salpingectomy (RRS)
Study Arms / Comparison Groups
Risk-Reducing Salpingectomy-RRS
Description: Can help to lower the risk of ovarian cancer with a delayed removal of 1.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
100
Start Date
May 10, 2022
Completion Date
December 26, 2026
Primary Completion Date
December 26, 2026
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 yearsfor
BRIP1, RAD51C, RAD51D
- Childbearing completed
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Karen Lu, MD, (713) 745-8902, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05287451
Organization ID
2021-1089
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Study Sponsor
Karen Lu, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
May 2022