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Which surgery best prevents ovarian cancer without harming sexual health?

NCT ID NCT02760849

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

374 people

The number who actually took part.

Started

May 2016

Expected to finish

May 2041

An estimate. End dates often move.

Lead sponsor

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

30 to 50 years

Sex

Female participants only

Healthy volunteers

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

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

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Siteman Cancer Center at Washington University

    St Louis, Missouri, 63110, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.