Which surgery best prevents ovarian cancer without harming sexual health?
NCT ID NCT02760849
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study looks at two types of surgery to prevent ovarian cancer in women aged 30-50 who have gene mutations that raise their risk. One surgery removes both the fallopian tubes and ovaries, while the other removes only the tubes first and delays removing the ovaries. The goal is to see which approach better lowers cancer risk while also protecting sexual function and emotional well-being.
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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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374 people
The number who actually took part.
- Started
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May 2016
- Expected to finish
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May 2041
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 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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. Women must be ≥ 30 and ≤ 50 years of age. 2. 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. 3. Willing to undergo two surgical procedures (if chooses the ISDO arm). 4. Presence of at least 1 fallopian tube and 1 ovary. Prior unilateral salpingectomy is allowed; prior bilateral salpingectomy is not allowed 5. Patients who have undergone a prior tubal ligation will be eligible. 6. Participants may have a personal history of non-ovarian malignancy, but must: 1. Be without evidence of disease at enrollment 2. Remain premenopausal 3. Have completed treatment (including surgery, chemotherapy, radiotherapy or hormonal therapy) \> 3 months prior to enrollment (other than non-melanoma skin cancer) 7. 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. 8. Patients must understand that they will be permanently sterilized Exclusion Criteria: 1. Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer. 2. Current treatment with Tamoxifen or Aromatase Inhibitors. 3. Medical comorbidities making surgery unsafe as determined by the patient's surgeon. 4. 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 HCG, or best judgment 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. 5. 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. 6. Inability to provide informed consent. 7. 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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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Siteman Cancer Center at Washington University
St Louis, Missouri, 63110, United States
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
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University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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