Phase
Condition
Ovarian Cancer
Ovarian Cysts
Vaginal Cancer
Treatment
Risk-Reducing Oophorectomy-RRO
RIsk-Reducing Salpingectomy (RRS)
Risk-Reducing Salpingo-Oophorectomy-RRSO
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 yearsfor BRIP1, RAD51C, RAD51D, and PALB2.
- The highest risk for cancer is mediated by the BRCA mutation. If a patient hasmultiple mutations, eligibility will be based on BRCA mutation.
No longer requires fallopian tubes for natural childbearing. Future plans for IVFare 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.
Exclusion
Exclusion Criteria:
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)
A postmenopausal state is defined as no menses for 12 months without analternative medical cause.
A high follicle stimulating hormone (FSH) level in the postmenopausal range maybe used to confirm a postmenopausal state in women not using hormonalcontraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can beconsidered.
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. AromataseInhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) areallowed.
Study Design
Study Description
Connect with a study center
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
WU St Louis
St Louis, Missouri 63130
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Mount Sinai Health System
New York, New York 10029
United StatesActive - Recruiting
Mount Sinai Health System
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Lyndon Baines Johnson General
Houston, Texas 77026
United StatesActive - Recruiting
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
University of Washington
Seattle, Washington 98195
United StatesActive - Recruiting

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