A study of a test called ROCA for women who have a high risk of developing ovarian cancer (ALDO)

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

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Other

This study is for women who have changes (mutations) in the BRCA1 or BRCA2 gene. People who have BRCA1 or BRCA2 mutations have a high risk of developing certain cancers, including ovarian cancer.

More about this trial

Genes are coded messages that tell cells how to behave. All cancers develop because something has gone wrong with one or more genes in a cell. A change in a gene is called mutation.

The BRCA1 and BRCA2 are genes that help to repair DNA. Doctors know that some of the mutations in these genes can increase the risk of developing certain cancers, including ovarian cancer.

Women who have the BRCA1 or BRCA 2 mutation can have surgery to remove their ovaries Open a glossary item

and fallopian tubes Open a glossary item

. This can stop ovarian cancer from developing. But some women can’t have surgery because of other health problems. And others might decide to delay surgery to:

have children
avoid early menopause

You may have routine check ups with your doctor if you can’t have surgery or if you decide to delay surgery. You may also have blood tests to check the levels of the CA-125 Open a glossary item

protein. The CA-125 levels are usually higher than normal in people with ovarian cancer.

In this study, researchers are looking at a test called ROCA. They think it can spot ovarian cancer earlier when treatment is likely to work better. The ROCA test calculates your risk of developing ovarian cancer by looking at:

the results of the CA-125 test
your age
whether you have started the menopause

The main aim of this study is to find out whether the ROCA test can help to find ovarian cancer earlier.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply. You:

have a change (mutation) in the BRCA1 or BRCA2 gene
have at least one ovary and one fallopian tube
are aged between 35 and 86 years old

Who can’t take part

You cannot join this study if any of these apply. You:

are pregnant or have been pregnant in the past 6 weeks
have had ovarian cancer or doctors think you might have it
have cancer or you have had treatment for cancer in the past 6 weeks

Trial design

Researchers hope that around 2,000 women will agree to take part. Everyone has blood tests every 4 months, for up to a year.

You go to your GP or local hospital to have the blood tests. After you have had the test, you send the small bottle with the blood sample to the study team using a pre paid envelope.

The study team:

tests your blood sample for the CA-125 protein
checks your risk of developing ovarian cancer

You get the results about a week afterwards.

If the results show that you have a high risk, it doesn’t mean that you have ovarian cancer. You have further tests such as more blood tests and a scan of your ovaries to find out more. Your doctor can tell you which tests you need to have.

Questionnaires

You complete some questionnaires as part of this study. The study team wants to find out your opinion about the ROCA test.

You complete the questionnaires before the start and at the end of this study. The team may also send you a questionnaire 18 months after your last blood test.

Hospital visits

You go to your GP or local hospital to have the blood tests every 4 months. This continues for up to a year.

You may need further tests if the ROCA test shows that you have a high risk of developing ovarian cancer. Your doctor can tell you which tests you need to have.

Side effects

Having a blood test is very safe and the study team doesn’t think you will have any serious side effects from it. You may have some bruising at the site of injection.