Prophylactic Salpingectomy With Delayed Oophorectomy

Running, not enrolling · Not applicable

Conditions studied: Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT01907789

Run by

M.D. Anderson Cancer Center

People needed

80

Starts

2013-08-26

Expected to finish

2030-12-31

Last updated by the study team

2026-04-16

Who can join

Age: 30 and older, up to 47. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Postmenopausal women or women < 30 or >/= 48 years of age.
• Women without a documented BRCA mutation.
• Women with a history of ovarian, fallopian tube, or primary peritoneal cancer.
• Women currently undergoing cancer treatment or with a known active cancer. History of malignancy is allowed as long as the patient has completed treatment > 3 months prior to enrollment.
• Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
• Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.
• Women who are pregnant. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgement of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
• Women desiring future fertility except in the screening arm of the trial.
• Women whose most recent CA125 or transvaginal ultrasound is abnormal. A history of abnormal CA125 or ultrasound is allowed, as long as the most recent testing is normal.
• Inability to provide informed consent.
• Inability to read or speak English.

Where it is running

• NorthShore University Health System — Evanston, Illinois, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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