Gender
Female
Age Group
30 Years to 50 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Premenopausal women with a documented deleterious mutation in one of the following
ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6,
MLH1, or PMS2, or EPCAM; (please note: menopause is defined as >= 12 months of
amenorrhea; however, for those patients with >= 12 months of amenorrhea who may be
pre-menopausal, levels of follicle-stimulating hormone [FSH], luteinizing hormone
[LH], and estradiol in the pre-menopausal range will be acceptable)
- Willing to undergo two surgical procedures (if participant chooses the ISDO arm)
- Presence of at least 1 fallopian tube and 1 ovary; (please note: prior unilateral
salpingectomy is allowed; prior bilateral salpingectomy is not allowed)
- Patients who have undergone a prior tubal ligation will be eligible
- Participants may have a personal history of non-ovarian malignancy, but must: a) be
without evidence of disease at enrollment b) remain premenopausal c) have completed
treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) > 3
months prior to enrollment (other than non-melanoma skin cancer)
- Willingness to return to the enrolling site for the study surgical procedures,
including pre-operative and post-operative care; (patients in the ISDO arm must be
willing to return to the enrolling site for yearly ovarian cancer assessment)
- Patients must understand that they will be permanently sterilized
Exclusion Criteria:
- Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer
- Current treatment with tamoxifen or aromatase inhibitors
- Medical comorbidities making surgery unsafe as determined by the patient's surgeon
- Women who are pregnant or post-partum (within 3 months of delivery); patients are
deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound,
beta human chorionic gonadotropin (HCG), or best judgement of the investigator;
pregnancy testing is not required per protocol to determine study eligibility; women
who become pregnant on the ISDO arm via reproductive technology can remain on study;
however, data collection will be suspended during pregnancy and 3 months post-partum
- Women with elevated levels of CA125 (> 50) or transvaginal ultrasound suggesting
cancer, unless findings are consistent with endometriosis; CA125 and transvaginal
ultrasounds must be the most recent, but no older than 1 year from the date of
enrollment
- Inability to provide informed consent
- Inability to read or speak English