RecruitingNAINTERVENTIONAL

Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

This study is for women under 40 who have changes in their womb lining (atypical endometrial hyperplasia) or early-stage womb cancer (grade 1 endometrial cancer). These conditions can affect a woman's ability to have children, and the usual treatment is removing the womb, which isn't suitable if you want to get pregnant. This research explores a keyhole surgery method called hysteroscopic resection. This procedure removes only the affected parts of the womb lining, rather than the whole womb. It's being tested in women whose conditions haven't improved with hormone-based treatments. The goal is to see if this keyhole surgery is a safe and effective way to treat these conditions while allowing women to preserve their fertility.

At a glance

Status

Recruiting

Phase

Sponsor

Vancouver Coastal Health Research Institute

Enrolment target

Start

15 Nov 2020

Estimated completion

01 Jul 2028

Endometrial Hyperplasia Endometrial Cancer Gynecologic Cancer

What is this study about?

Womb cancer (endometrial cancer) and a condition called atypical endometrial hyperplasia (AH), which can sometimes turn into cancer, are common health issues for women. Often, the most effective treatment for these conditions is an operation to remove the womb (a hysterectomy). However, this can be very difficult news for younger women who still want to have children.

While some women respond to hormone treatments to manage these conditions, it doesn't always work. If hormone therapy isn't successful, surgery is usually needed. This study is looking into a different kind of surgery for women who specifically want to keep their ability to have children. It's called hysteroscopic endomyometrial resection, which is a keyhole procedure where a surgeon carefully removes only the parts of the womb lining that are affected, leaving the rest of the womb in place.

The main idea behind this study is to see if this keyhole surgery is a safe and effective option for treating AH or early womb cancer, especially when hormone treatments haven't helped. The research team includes different specialists, like gynaecologists and fertility experts, to make sure all aspects of your health and future plans are considered. They will carefully check participants throughout the study to ensure this treatment is both safe and works well.

Key takeaways

This study is for early womb lining issues or early womb cancer.
It's for women under 40 who want to preserve their fertility.
It uses a keyhole surgery if hormone therapy hasn't worked.
The aim is to treat the condition without removing the whole womb.
Careful monitoring will be part of taking part in the study.

Who may be eligible?

This study is specifically for women who are under 40 years old and have been diagnosed with either atypical endometrial hyperplasia or early-stage grade 1 endometrial cancer. You must have already tried hormone therapy for these conditions, but it didn't work for you, or you couldn't tolerate the side effects.

To be considered, scans and a close look at your womb will be done to make sure the problem area is small enough to be treated with this keyhole procedure. It's also really important that you want to preserve your fertility to have children and that a fertility specialist believes you have a reasonable chance of getting pregnant.

Unfortunately, you wouldn't be able to join if you are 40 or older, have a more advanced or different type of womb cancer, or if the affected area in your womb is too large. Also, if you have other serious health conditions that would make surgery too risky, you wouldn't be suitable for this study.

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.

Are you under 40 years old?
Have you been diagnosed with atypical endometrial hyperplasia or Grade I early womb cancer?
Have you tried hormone therapy, but it didn't work or had bad side effects?
Do you want to get pregnant in the future?
Do you have a fertility specialist's opinion that you have a reasonable chance to conceive?
Do you have any other serious health conditions that might make surgery risky?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a detailed check-up of your womb using a small camera (hysteroscopy) to confirm if this treatment is right for you. Your case will be discussed by a team of experts to ensure you meet all the criteria for the keyhole surgery.

The main part of taking part involves having the hysteroscopic resection procedure. After the surgery, you will be carefully monitored over time. This involves regular check-ups and possibly further scans or biopsies to make sure the treatment has worked and that you remain healthy. The exact number of visits and their duration will be explained fully by the study team, but close follow-up is essential to ensure the treatment is safe and effective in the long run. The total duration of your participation will depend on the monitoring schedule.

Potential risks and benefits

Potential benefits of taking part include receiving treatment for your womb condition while having the chance to preserve your fertility, which might not be an option with traditional surgery. This study could help find a new way for women to have children after this diagnosis. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or damage to the womb. There's also a risk that the treatment might not be successful, or the condition could return, potentially requiring further treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Vancouver General Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'atypical endometrial hyperplasia'?

It's a condition where the cells lining your womb grow abnormally, and it can sometimes become early womb cancer.

What is 'Grade I endometrial cancer'?

This is the earliest and least aggressive type of womb cancer.

What does 'hysteroscopic uterine resection' mean?

It's a keyhole procedure where a surgeon uses a thin tube with a camera to look inside your womb and remove only the problem areas of the lining.

Why is this treatment only for women who want children?

The goal of this specific study is to help women preserve their ability to have children, as the standard treatment often involves removing the womb entirely.

What if hormone therapy didn't completely clear my condition?

This study is for women whose conditions haven't been successfully treated by hormone therapy.

How to find out more

Neeraj Mehra, MD

neeraj.mehra@ubc.ca 604-875-5508 Official trial record

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