A study looking at screening the general population for ovarian cancer (UKCTOCS)

This study is looking at whether screeing tests would be useful for diagnosing ovarian cancer in the general population.

At the moment there is no screening programme for ovarian cancer in the general population. This is because the tests that are used in a screening programme have to be reliable and accurate. Doctors are not sure yet if the tests available at the moment are good enough to detect ovarian cancers early.

In the UKCTOCS trial, they are comparing 2 screening tests with no test at all. The women who have screening will either have a CA 125 blood test or a transvaginal ultrasound scan. These tests will be done on women who have been through the menopause.

The aim of the trial is to see if either of these tests will help doctors diagnose women with ovarian cancer when their cancer is at an early stage. If the tests work well enough it could mean that women with ovarian cancer may be diagnosed earlier, and their cancer treated more effectively.

Please note that you are not able to volunteer to take part in this trial. Women are being chosen at random from Health Authority lists. If you are invited to take part, the research team will send you a letter.

Please note this trial is no longer recruiting patients.

Recruitment

Start 31/01/2001

End 29/09/2005

Phase

Other

Who can enter

You can enter this trial if you

Are invited to take part
Are aged between 50 and 75
Have not had periods for one year

You cannot enter this trial if you

Have had surgery to remove both of your ovaries
Have been diagnosed with ovarian cancer in the past
Have had any other cancer in the past that has not been effectively treated
Have had treatment for cancer within the last year
Are at a high risk of developing ovarian cancer because of your family history
Are taking part in any other ovarian cancer screening trial

Trial design

This trial will recruit 200,000 women from around the UK. It is a randomised trial and has 3 groups. The women taking part will be put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in

Group 1, you will not have any screening
Group 2, you will have CA 125 blood test once a year. If the level of CA 125 in your blood is raised, you will then have a transvaginal ultrasound scan
Group 3, you will have a transvaginal ultrasound scan done using a probe inserted into the vagina. This will be done once a year. If this scan shows anything abnormal on your ovaries, it will be repeated after 6 to 8 weeks. This is because most abnormalities seen will go away on their own and not need any more treatment

If any of the test results indicate that you may have ovarian cancer at any stage during the trial, you will be referred to a specialist and given any treatment you need.

You will have a blood sample taken when you first join the trial. This will not be tested at that time, but will be stored. This blood sample may be used to assess new tests for ovarian cancer that are developed in the future.

You will be asked to fill out a questionnaire before you start the trial, and 3 years and 7 years after you start the trial. This will ask you how you feel about screening, and about your health. The questionnaire will be sent out in the post.

About 1000 women will also be asked to fill out another questionnaire yearly for 6 years. This questionnaire will ask you about your emotional well being and sexual activity. The purpose of the questionnaires is to see if having regular screening has an emotional or psychological effect on women.

Hospital visits

If you are in group 2 or 3, you will need to go to the hospital once a year for 6 years. You will have either the blood test or transvaginal ultrasound scan depending which group you are in.

There is more information about UKCTOCS on the trial website.

Side effects

There are no side effects, apart from the needle pricks for the blood tests. Ultrasound scans use sound waves and do not have side effects.

If the tests show that you may have ovarian cancer, you may need further investigation and possibly treatment. But only 1 out of 5 women who have a raised CA125, and 1 out of 15 women who have something abnormal seen on their ultrasound scan will have ovarian cancer. The majority of abnormal results are caused by something other than cancer.