Active — Not RecruitingNot Applicable

Prophylactic Salpingectomy With Delayed Oophorectomy

United States80 participantsStarted 2013-08-26

Plain-language summary

The goal of this clinical research study is to compare ovarian cancer screening, risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied. Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams, blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal cancer. The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer. In RRSO, the fallopian tubes and ovaries are removed at the same time. In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient does not go through menopause. The ovaries are removed at a later date. The main goal of this study is to learn how many patients actually have their ovaries removed at a later date. Researchers also want to learn whether the removal of fallopian tubes will decrease the risk of ovarian cancer.

Who can participate

Age range30 Years – 47 Years

SexFEMALE

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Inclusion criteria

✓. Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as \>/= 12 months of amenorrhea.
✓. Women must be at least 30 and less than 48 years of age.
✓. Candidate for surgery and willing to undergo two surgical procedures (if chooses the PSDO arm).
✓. Patient choosing PSDO or RRSO must desire permanent sterilization.
✓. Presence of at least one fallopian tube. Prior tubal ligation is allowed.
✓. Participants may have a personal history of non-ovarian malignancy, but must be without evidence of disease at enrollment and the patient must have completed treatment (including surgery, chemotherapy, or radiotherapy) \> 3 months prior to enrollment (other than non-melanoma skin cancer). Current or past SERM or aromatase inhibitor use is allowed.
✓. Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care.
✓. Willingness to return to the enrolling site for ovarian cancer screening during the study period.

Exclusion criteria

What they're measuring

Patient Compliance with Prophylactic Salpingectomy with Delayed Oophorectomy Strategy

Timeframe: Up to 5 years

Trial details

NCT IDNCT01907789

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

View on ClinicalTrials.gov More Ovarian Carcinoma trials