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
2 other identifiers
interventional
100
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable ovarian-cancer
Started May 2022
Typical duration for not_applicable ovarian-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 26, 2026
April 15, 2026
April 1, 2026
4.6 years
February 7, 2022
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
through study completion, an average of 15 years
Study Arms (3)
Risk-Reducing Salpingectomy-RRS
OTHERCan help to lower the risk of ovarian cancer with a delayed removal of 1.
Risk-Reducing Oophorectomy-RRO
OTHERCan help to lower the risk of ovarian cancer removing both fallopian tubes.
Risk-Reducing Salpingo-Oophorectomy-RRSO
OTHERCan help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO)
Interventions
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 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, and PALB2
- 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.
You may not qualify if:
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
WU St Louis
St Louis, Missouri, 63130, United States
Mount Sinai Health System
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Lyndon Baines Johnson General
Houston, Texas, 77026, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roni Wilke, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2022
First Posted
March 18, 2022
Study Start
May 10, 2022
Primary Completion (Estimated)
December 26, 2026
Study Completion (Estimated)
December 26, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04