RecruitingOBSERVATIONAL

DOvEEgene Fleur: New Uterine Sampling Tool

This study is looking at a new, gentler method for collecting cell samples from inside the womb. The main goal is to find womb (endometrial), fallopian tube, and ovarian cancers earlier and with less discomfort for the patient. Researchers developed this new tool, called the DOvEEgene Fleur, as part of a larger project to create a reliable test for these cancers. The current sampling tool can be quite painful, so the new tool is designed to be much more comfortable while still being effective at finding tiny traces of cancer cells. This research hopes to improve how we diagnose these cancers, making it a better experience for women.

At a glance

Status

Recruiting

Sponsor

McGill University

Enrolment target

Start

11 Dec 2020

Estimated completion

01 Oct 2026

Women With Suspected or Confirmed Gynecological Disease

What is this study about?

This research is focused on finding clever ways to detect certain types of cancer very early. Specifically, it's looking at cancers of the womb (endometrium), fallopian tubes, and ovaries. The idea is that even at early stages, these cancers might shed tiny bits of their genetic material (DNA) into the womb, which can then be collected and tested. Imagine it like a Pap test for the cervix, but designed to look higher up inside the body.

Researchers have been working on this for a while, developing a special test they call DovEEgene. So far, they've used a tool called the TAO brush to collect samples from inside the womb. However, they've found that this brush can be quite uncomfortable for patients, often causing moderate pain. That's why this particular study is important: it's introducing and testing a brand new tool, called the DOvEEgene Fleur.

The DOvEEgene Fleur is designed to be much gentler and cause less pain than the current TAO brush. The hope is that it will collect cancer cells just as well, if not better, but with much more comfort for women. By finding these cancers early, it can make a big difference in treatment and outcomes.

Key takeaways

This study tests a new, gentler tool for womb sampling.
The aim is to detect womb, fallopian tube, and ovarian cancers early.
The new tool aims to be more comfortable than current methods.
Participation involves a quick sample collection during your planned surgery.
Findings could improve future cancer diagnosis for women.

Who may be eligible?

To join this study, you need to be at least 18 years old and be able to understand what the study involves and agree to take part. You must either be suspected of having, or already have, cancer in your upper female reproductive organs (like the womb, fallopian tubes, or ovaries) and be scheduled for surgery to remove the tumour.

There are also some reasons why you wouldn't be able to join. For example, if you've already had your womb removed (a hysterectomy), or if you are pregnant, might be pregnant, or are breastfeeding. You also can't join if you have any infections in your cervix, pelvis, or vagina, or if you've recently had a hole in your womb. If you've had treatment for abnormal cells on your cervix, you'd need to have normal Pap smear results at least four months after that treatment to be considered.

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 at least 18 years old?
Do you have a suspected or confirmed gynaecological cancer and are scheduled for surgery?
Are you not pregnant or breastfeeding?
Do you not have any active infections in your gynaecological area?
Have you not had a recent womb perforation or hysterectomy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a sample collected from inside your womb using the new DOvEEgene Fleur tool. This procedure will happen during your usual care, specifically when you are already undergoing surgery for a suspected or confirmed tumour in your upper female reproductive organs. There are no additional visits or medications required outside of your planned surgical schedule. The sampling itself is a quick procedure. You will be asked to complete a short comfort assessment after the procedure using a pain scale. The total duration of your participation, beyond the sample collection, is minimal.

Potential risks and benefits

The potential benefits of taking part include helping researchers develop a less painful and more effective way to detect cancers of the womb, fallopian tubes, and ovaries. This could lead to earlier diagnosis for many women in the future. Potential risks are expected to be low, as the new tool is designed to be gentler. However, as with any medical procedure, there's a small chance of discomfort or other unexpected issues, though serious complications are rare. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Royal Victoria Hospital (Glen Site)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What exactly does the new sampling tool do?

It's designed to gently collect cells from inside your womb to look for very early signs of cancer, similar to how a Pap test works for the cervix.

Will this new tool hurt?

The goal of this new tool, called the DOvEEgene Fleur, is to be much more comfortable and cause less pain than the older tool currently used for womb sampling.

Why is early detection important for these cancers?

Finding cancers like those in the womb, fallopian tubes, and ovaries at an early stage often leads to more effective treatment and better outcomes.

Is this sampling procedure part of my regular treatment?

The sample will be collected while you are already having surgery for a suspected or confirmed tumour, so it won't be an extra trip to the hospital.

What kind of cancer does this study focus on?

It focuses on cancers that affect the womb (endometrial), fallopian tubes, and ovaries.

How to find out more

Dr. Lucy Gilbert, MD,MSc,FRCOG

lucy.gilbert@mcgill.ca (514) 934-1934 Official trial record

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