A trial comparing different ways of working out whether an ovarian cyst is cancerous (IOTA 4)

Coronavirus (COVID-19)

We know that this is an especially worrying time for people with cancer and their family and friends. We have separate information about coronavirus and cancer. Please read that information alongside this page. We will update that information as guidance changes.

Read about coronavirus and cancer

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 4

This trial looked at a new way of deciding whether or not an ovarian cyst could be cancerous.

More about this trial

It is important that doctors have a way of working out the treatment you need to have if you have a cyst on an ovary. You have surgery to remove it if your doctor thinks the cyst is cancerous. 

But if a cyst isn’t cancerous, you might not need to have it removed. Or if you do have surgery you might be able to have a smaller operation called a laparoscopy.

At present, doctors use a system called the Risk of Malignancy Index (RMI) to assess ovarian cysts. This system looks at the results of an ultrasound scan, along with a blood test for a marker called CA125. But the amount of CA125 in your blood can be raised for a number of reasons other than cancer. 

Researchers have developed a new way of assessing ovarian cysts based on information from the ultrasound scan, and other details such as your age, but without using the CA125 test. This new system, known as LR2 has already been widely used in studies across Europe.

In this trial, they compared the 2 ways of assessing ovarian cysts in women who have already had an ultrasound scan that showed a cyst. 

Summary of results

The team found that the LR2 system did correctly identify more cancerous growths and non cancerous (benign Open a glossary item) growths on the ovaries than the RMI system. 

This was a phase 4 trial. It was a randomised trial. The women who took part were put into 1 of 2 groups by a computer.

232 women took part and researchers were able to look at the results of 193 women. 

  • 92 women were assessed using the LR2 system
  • 101 women were assessed using the RMI system

study diagram

The team looked at how many women’s ovarian cysts were correctly assessed in each group. They found it was:

  • 86 women’s ovarian cysts (93.5%) were in the LR2 group
  • 67 women’s ovarian cysts (66%) were in the RMI group

Because there is a higher risk of ovarian cancer for post menopausal women, the team also looked at the results according to whether the women had been through the menopause Open a glossary item (post menopausal) or hadn’t been through the menopause (pre menopausal). They found that the LR2 system was better at assessing the ovarian cysts in both groups. 

The researchers looked at the percentage of benign growths identified that had a low risk of becoming cancer. This is called the safety potential ratio. 

They found that the LR2 system had a higher safety potential ratio than the RMI system. This was also the case when the results were split into post menopausal and pre menopausal groups. 

They also looked at the percentage of cancerous growths identified that had a moderate to high risk of coming back. This is called the potential efficacy ratio. 

The team found that there was no significant difference between the LR2 system and the RMI system in the potential efficacy ratio. Even when they looked at the results according to whether women were pre or post menopausal. 

The trial team concluded that the LR2 system was better than the RMI system at identifying and assessing ovarian cysts.  

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) but may not have been published in a medical journal.  The figures we quote above were provided by the research team. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Tom Bourne
Ahmad Sayasneh (Lead Researcher and Trial Co-ordinator)

Supported by

Imperial College Healthcare NHS Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10699

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think