Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy
Clinicaltrials.gov identifier:
NCT05287451
Prevention
Prevention study for women at high risk for ovarian cancer
Study Contact Information:
Contact: Roni Wilke, MD
by phone: (713) 822-4502
or by email: rnitecki@mdanderson.org
Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High-Risk Women (TUBA/WISP II)
About the Study
This study is looking at whether removal of the () followed by removal of the ovaries () at a later date closer to the time of natural menopause may reduce the risk of ovarian cancer nearly as much as removing both the ovaries and at the same time (salpingo-oophorectomy) among women with an inherited , , , or mutation. Removing the only first and the ovaries at a later time closer to natural menopause may lessen menopausal symptoms while still lowering the risk for ovarian cancer.
What the Study Involves
Participants in this study will enroll in one of two groups. Participants will choose which group they enroll in based on their surgical preference.
- Group 1 will include women who choose risk-reducing removal of () with delayed .
- Group 2 will include women who choose removal of both and ovaries at the same time, (salpingo-oophorectomy) which is considered standard-of-care.
Study Sites
Massachusetts
Boston
Harvard Cancer Center
Contact: Colleen Feltmate, MD by phone 617-732-8843 or email cfeltmate@bwh.harvard.edu
Missouri
St. Louis
Washington Univeristy School of Medicine
Contact: Andrea Hagemann, MD by phone 314-362-3181 or by email hagemann@wustl.edu
Texas
Houston
M D Anderson Cancer Center
Contact: Roni Wilke, MD by phone (713) 822-4502 or by email: rnitecki@mdanderson.org
Washington
Seattle
University of Washington Cancer Center
Contact: Barb Norquist, MD by email: bnorquis@uw.edu or contact the study coordinator at: 206-616-3913
Women are eligible if they:
- Are premenopausal with a documented in one of the genes listed below. Eligible age depends on gene mutation.
- BRCA1: 25-40
- BRCA2: 25-45
- BRIP1: 30-50
- RAD51C: 30-50
- RAD51D: 30-50
- Have at least one
- Do not wish to be pregnant in the future
Women cannot participate if they:
- are post-menopausal (either naturally or due to cancer treatment)
- wish for second removal of ovaries within 2 years of removing
- have a personal history of ovarian/fallopian tube or peritoneal cancer
- have had prior removal of the ()