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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
WU St Louis
RECRUITING
St Louis
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Mount Sinai Health System
RECRUITING
New York
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
Lyndon Baines Johnson General
RECRUITING
Houston
M D Anderson Cancer Center
RECRUITING
Houston
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Roni Wilke, MD
rnitecki@mdanderson.org
(713) 822-4502
Time Frame
Start Date: 2022-05-10
Estimated Completion Date: 2026-12-26
Participants
Target number of participants: 100
Treatments
Other: Risk-Reducing Salpingectomy-RRS
Can help to lower the risk of ovarian cancer with a delayed removal of 1.
Other: Risk-Reducing Oophorectomy-RRO
Can help to lower the risk of ovarian cancer removing both fallopian tubes.
Other: Risk-Reducing Salpingo-Oophorectomy-RRSO
Can 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)
Authors
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov