RECRUITINGINTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2
3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable
4. Presence of at least one fallopian tube
5. Participants may have a personal history of non-ovarian malignancy
6. willing to sign a consent form must be obtained and documented.
Who Should NOT Join This Trial:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Postmenopausal status (natural menopause or due to (cancer) treatment)
2. Wish for second stage RRO within two years after RRS (if clear at enrollment)
3. Legally incapable
4. Prior bilateral salpingectomy
5. A personal history of ovarian, fallopian tube, or peritoneal cancer
6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and/or RAD51D gene germline mutation.
2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2
3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable
4. Presence of at least one fallopian tube
5. Participants may have a personal history of non-ovarian malignancy
6. Informed consent must be obtained and documented.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Postmenopausal status (natural menopause or due to (cancer) treatment)
2. Wish for second stage RRO within two years after RRS (if clear at enrollment)
3. Legally incapable
4. Prior bilateral salpingectomy
5. A personal history of ovarian, fallopian tube, or peritoneal cancer
6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.
Treatments Being Tested
OTHER
RIsk-Reducing Salpingectomy (RRS)
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
OTHER
Risk-Reducing Oophorectomy-RRO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
OTHER
Risk-Reducing Salpingo-Oophorectomy-RRSO
complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
Locations (9)
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
WU St Louis
St Louis, Missouri, United States
Mount Sinai Health System
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lyndon Baines Johnson General
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States