RecruitingNAINTERVENTIONAL

TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

This study is investigating a new surgical option for women at high risk of ovarian cancer due to specific gene mutations like BRCA1 or BRCA2. Currently, women with these gene changes often have both their ovaries and fallopian tubes removed (called risk-reducing salpingo-oophorectomy) around age 40 to significantly cut down their cancer risk. However, this surgery causes immediate menopause. This study is exploring a different approach: first removing only the fallopian tubes (risk-reducing salpingectomy), and then removing the ovaries later (delayed oophorectomy). The goal is to see if this two-step surgery is as safe and effective at preventing ovarian cancer, while also delaying the start of menopause and its associated health issues. We want to make sure this new method works well before it becomes a standard option.

At a glance

Status

Recruiting

Phase

Sponsor

University Medical Center Nijmegen

Enrolment target

3,000

Start

01 Mar 2020

Estimated completion

17 Feb 2040

BRCA1 Gene Mutation BRCA2 Gene Mutation RAD51C Gene Mutation RAD51D Gene Mutation BRIP1 Gene Mutation Ovarian Cancer

What is this study about?

For some women, having certain changes in genes like BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1 means they have a much higher chance of developing ovarian cancer. Because ovarian cancer can be hard to spot early and is often advanced when found, doctors usually recommend a surgery where both ovaries and fallopian tubes are removed. This surgery significantly lowers the risk of ovarian cancer, but it also causes menopause to start right away, which can bring on symptoms like hot flushes, mood changes, and long-term health concerns like weaker bones.

Recent research suggests that many ovarian cancers actually start in the fallopian tubes. This study is looking at a new idea: what if we only remove the fallopian tubes first, and wait to remove the ovaries until later? The hope is that this two-step surgery could still protect against ovarian cancer effectively, but allow women to keep their ovaries for longer, delaying menopause and its effects.

We need to thoroughly check if this new approach is just as safe and effective as the current surgery in preventing ovarian cancer in the long run. This study will help us understand if removing the fallopian tubes first, and the ovaries later, is a good option for women at high risk. Your participation would help medical science move forward and potentially offer more choices for women in the future.

Key takeaways

This study explores a new way to reduce ovarian cancer risk.
It involves removing fallopian tubes first, ovaries later, to delay menopause.
It's for women with specific gene changes like BRCA1/2.
The goal is to see if this new method is safe and effective.
Participation could help improve future treatment options for others.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women who have been found to have specific changes in genes like BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1. You would need to be within certain age ranges, for example, 25-40 for BRCA1, 25-45 for BRCA2, and 25-50 for the other gene changes mentioned. It's important that you have finished having children and still have at least one fallopian tube.

There are also some reasons why you might not be able to join. These include if you have already gone through menopause, or if you have already had both fallopian tubes removed. You also can't participate if you have ever had ovarian, fallopian tube, or a type of abdominal cancer called peritoneal cancer, or if you are currently being treated for any other type of active cancer.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have specific gene changes (BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1).
I am within the specified age range for my gene change.
I have finished having children.
I have at least one fallopian tube.
I have not gone through menopause yet.
I have not had ovarian, fallopian tube, or peritoneal cancer before.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would have an operation where only your fallopian tubes are removed. After this surgery, you would have regular check-ups with your medical team. The study will follow you over time to see how you are doing and to monitor your health. At a later point, you would have a second operation to remove your ovaries. Your involvement would include attending appointments, having tests, and providing information about your health. The total duration of your participation would cover the time from your first surgery through to your second surgery and subsequent follow-up, which could be several years.

Potential risks and benefits

Potential benefits of participating could include receiving leading-edge care and contributing to important research that might offer more options for future high-risk women. The key benefit of this approach, if proven safe and effective, is the delay of menopause. However, all surgeries carry some risks, including infection, bleeding, and reactions to anaesthesia. There's also the unknown of whether this new approach will be as effective at preventing cancer as the established surgery. You have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (66)

UChicago Medicine
Verified postcode
Chicago, United States· Recruiting
Dana Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Recruiting
Washington University Medical Center
Verified postcode
St Louis, United States· Recruiting
Mount Sinai Hospital
Verified postcode
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Duke University Hospital
Verified postcode
Durham, United States· Recruiting
Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting
Harris Health Lyndon B. Johnson Hospital
Verified postcode
Houston, United States· Recruiting
MD Anderson Cancer Centre
Verified postcode
Houston, United States· Recruiting
University of Washington
Verified postcode
Seattle, United States· Recruiting
Chris O'Brien Lifehouse
Verified postcode
Sydney, Australia· Recruiting

Common questions

What's the main difference between this new surgery and the usual one?

The usual surgery removes both fallopian tubes and ovaries at the same time. This new approach involves removing only the fallopian tubes first, and the ovaries later, to delay menopause.

Why is delaying menopause important?

Removing ovaries causes immediate menopause, which can bring unwanted symptoms and long-term health concerns like weaker bones. Delaying it can improve quality of life.

Will I still be protected from cancer if I only have my fallopian tubes removed first?

That's exactly what this study aims to find out. Evidence suggests many ovarian cancers start in the fallopian tubes, so this strategy is being investigated for its effectiveness.

Who is funding this research?

Information about specific funding bodies is not provided, but such studies are usually supported by medical research organisations or government grants.

What happens if I change my mind after joining?

You have the right to stop participating in the study at any time without needing to give a reason, and this won't affect your future medical care.

How to find out more

Joanne A. de Hullu, MD, PhD

joanne.dehullu@radboudumc.nl +31 (0) 24 36 16683 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.