New study tests two-step surgery to delay menopause while cutting ovarian cancer risk
NCT ID NCT01907789
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at three approaches to prevent ovarian cancer in women with BRCA1 or BRCA2 gene mutations: regular screening, removing both fallopian tubes and ovaries at once, or removing only the fallopian tubes first and the ovaries later. The two-step surgery aims to delay menopause and its side effects. About 80 premenopausal women aged 30-47 are taking part to see how many complete the delayed ovary removal and whether the fallopian tube removal alone lowers cancer risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2013
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 47 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as \>/= 12 months of amenorrhea. 2. Women must be at least 30 and less than 48 years of age. 3. Candidate for surgery and willing to undergo two surgical procedures (if chooses the PSDO arm). 4. Patient choosing PSDO or RRSO must desire permanent sterilization. 5. Presence of at least one fallopian tube. Prior tubal ligation is allowed. 6. 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. 7. Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care. 8. Willingness to return to the enrolling site for ovarian cancer screening during the study period. Exclusion Criteria: 1. Postmenopausal women or women \< 30 or \>/= 48 years of age. 2. Women without a documented BRCA mutation. 3. Women with a history of ovarian, fallopian tube, or primary peritoneal cancer. 4. 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. 5. Medical comorbidities making surgery unsafe as determined by the patient's surgeon. 6. Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed. 7. 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. 8. Women desiring future fertility except in the screening arm of the trial. 9. 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. 10. Inability to provide informed consent. 11. Inability to read or speak English.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NorthShore University Health System
Evanston, Illinois, 60201, United States
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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