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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: Karen Lu, MD
by phone: 713-745-8902
or by email: [email protected]  


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 [email protected]

Missouri
St. Louis
Washington Univeristy School of Medicine
Contact: Andrea Hagemann, MD by phone 314-362-3181 or by email [email protected]

Texas
Houston
M D Anderson Cancer Center
Contact: Karen Lu, MD by phone: 713-745-8902 or by email [email protected]  

Washington
Seattle
University of Washington Cancer Center
Contact: Barb Norquist, MD by email: [email protected] or contact the study coordinator at: 206-616-3913

This Study is Open To:

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 
This Study is Not Open To:

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 (