A trial comparing 2 ways of examining and managing ovarian swellings

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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Ovarian cancer





This trial is comparing the standard assessment for ovarian swellings with a new way of looking at ultrasound scans, to see if the number of operations for harmless swellings (cysts) could be reduced.

Swellings of the ovary are common, and are often picked up on an ultrasound scan. Although most of these swellings aren’t cancerous, all women are offered a blood test for a chemical called CA125 Open a glossary item. This can help to diagnose ovarian cancer, although CA125 can be raised for many reasons other than cancer.

If the blood test shows raised levels of CA125, or the ovarian cyst looks complex, doctors advise women to have it removed, just in case. Many of these operations could be avoided if an ultrasound was better for telling apart cancerous and non cancerous swellings of the ovary.

Researchers in this trial are comparing 2 ways of examining and managing ovarian swellings. Women in the first group will have an ultrasound and blood test, using the standard assessment called RMI RCOG. The assessment for women in the second group is based on an ultrasound scan and uses a system called ‘Simple Rules’. The researchers use 10 rules to assess the swellings. Five rules predict cancer, and 5 rules predict that a swelling is benign. The score after all 10 rules helps predict whether the swelling is cancerous.

The aim of this trial is to see whether using Simple Rules could reduce the number of operations for harmless ovarian swellings.

Who can enter

You may be able to enter this trial if you

  • Are over 40, and have not had a period for at least a year (and your periods did not stop as a result of medication or illness) or you are over 50, and you have had a hysterectomy Open a glossary item

And you

  • Have a fluid filled sac or solid lump on or in your ovary (ovarian cyst Open a glossary item), or on the surrounding tissue or
  • Don’t have any unexplained pain or bloating, but your doctor thinks you should have further tests

You cannot enter this trial if you

  • Are still having periods
  • Have pain where your cyst is, or in the area between your hip bones (pelvis)
  • Are not fit enough for surgery
  • Have only one cyst on one ovary, that is clearly a single sac of clear fluid and it is smaller than 2cm – you can ask your doctor about this
  • Are below 40 or above 80 years old

Trial design

This trial will recruit 148 women. It is randomised. The women taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, the team will assess your cyst by following the RMI RCOG guidelines. You will have an ultrasound scan and a blood test to measure a chemical called CA125.

If you are in group 2, the team will assess your cyst using just an ultrasound scan following the set of simple rules.

Comparing 2 ways of examining and managing ovarian swellings trial diagram

To have an ultrasound scan, the radiographer will gently put a thin scanning probe into your vagina. This is called a transvaginal scan. If your swelling is higher up in your tummy the radiographer will take pictures by moving another probe over your tummy.

Depending on your results (whichever group you are in), you will have one of the following, which are not part of the trial

  • Surgery to remove the swelling
  • Check ups every 4 months for a year
  • An appointment to see a specialist doctor who deals with possible cancers

If you begin to have pain you can see the trial doctors again sooner.

The team will also collect basic medical information from you and your medical notes. They will use everyone’s information along with the assessment results and treatment outcomes to see whether the ‘simple rules’ can help reduce the number of operations for harmless cysts.

Hospital visits

Women in both groups will visit the hospital once for either their ultrasound and blood test, or their simple rules ultrasound.

These are the only hospital visits you have as part of this study. The total number of visits you have will depend on any treatment you may have.

Side effects

You may have a small bruise if you give a blood sample for the trial.

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

Miss Natalie Nunes

Supported by

University College London (UCL)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9703

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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