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Surgery in Preventing Ovarian Cancer in Patients with Genetic Mutations
Trial Status: temporarily closed to accrual
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
Women must be >= 30 and =< 50 years of age
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, PMS2, or EPCAM
* 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
* 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02760849.
I. To examine changes in female sexual function with the strategy of interval salpingectomy and delayed oophorectomy (ISDO) compared to the strategy of risk-reducing salpingo-oophorectomy (RRSO) for patients who carry genetic mutations that predispose them to ovarian cancer.
SECONDARY OBJECTIVES:
I. To estimate the onset and severity of menopausal symptoms with ISDO compared to RRSO.
II. To estimate quality of life with ISDO compared to RRSO.
III. To examine participants’ satisfaction level and cancer worry level with their choice of prophylactic procedures.
IV. To estimate the impact of ISDO compared to RRSO on mental health, including depression, anxiety, and sleep quality.
V. To determine the compliance with delayed oophorectomy within the ISDO arm.
VI. To estimate the number of fallopian tube, ovarian, or primary peritoneal malignancies and other malignancies over the course of the study.
VII. To identify common themes regarding influential factors in the decision to undergo risk-reducing surgery in premenopausal women at genetic high-risk for ovarian cancer.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients undergo ISDO.
ARM II: Patients undergo RRSO.
After completion of study treatment, patients are followed up at 1 and 6 months, 1 year, and 2 years.
