Stand up to Cancer: WISP Trial (Women Choosing Surgical Prevention)

This phase II trial studies how well surgery works in preventing ovarian cancer in patients
with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO)
is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy
with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known
whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the
sexual function and psychosocial well-being in patients with genetic mutation.

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