"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing 2 ways of examining and managing ovarian swellings
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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
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
- Have a fluid filled sac or solid lump on or in your ovary (
ovarian cyst), 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
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.
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.
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.
You may have a small bruise if you give a blood sample for the trial.
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.
Miss Natalie Nunes
University College London (UCL)