Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations (NCT02760849) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations
United States374 participantsStarted 2016-05-02
Plain-language summary
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.
Who can participate
Age range30 Years – 50 Years
SexFEMALE
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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 FSH, LH, and estradiol in the pre-menopausal range will be acceptable.
✓. Willing to undergo two surgical procedures (if 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:
✓. Be without evidence of disease at enrollment
✓. Remain premenopausal
Exclusion criteria
What they're measuring
1
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score
. 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).
✕. 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.