A study looking at current tests for ovarian cancer to help improve diagnosis (ROCKeTS)

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

We know that a lot of women have symptoms such as bloating and tummy discomfort. It is also very common to have swellings (cysts) on women’s ovaries picked up on an ultrasound scan. But only a very small number of these women will go on to be diagnosed with ovarian cancer.

More about this trial

Current guidelines for GP’s are to test women who have symptoms of tummy pain or bloating with a blood test called CA125, followed by an ultrasound scan if the blood test result is raised. But there are a number of other conditions that can cause a CA125 blood test to be raised. And CA125 is only raised in half the number of women who have early ovarian cancer. This means that many women referred have a low risk of cancer and others aren’t referred until their cancer is more advanced. Also, in younger women, it is common to have ovarian cysts that aren’t cancerous

The researchers in this trial think that collecting information about current tests could help to identify better tests in the future and this may help to improve diagnosis.

The aims of the study are to

Help diagnose ovarian cancer earlier when treatment is likely to work better
Help identify which women need further investigations for possible ovarian cancer and reduce unnecessary tests, hospital visits and distress in women who do not have ovarian cancer

Joining this study will not change your treatment, and you may not get any direct benefit from taking part. The researchers hope that the information they collect will help to improve diagnosis for women with ovarian cancer in the future.

Who can enter

Please note, from the end of November 2018, you can't join the study if you are postmenopausal. You may now only join if you are premenopausal.

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

have symptoms such as bloating or tummy pain or other symptoms that could possibly be ovarian cancer. And you also have 1 of the following
- a raised CA125 blood test result
- an abnormal ultrasound scan result showing a lesion that might be a cyst
- both a raised CA125 blood test result and an abnormal scan result

As well as the above, you

are willing to have a tummy or transvaginal scan
are due to have surgery to remove the lesion or give a sample of tissue (biopsy )
are 16 to 55 if you are still having your period (menstruating). If you aren't menstruating then you must be 15 to 55 to join.

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

have had ovarian cancer in the past
have had any other cancer in the last year apart from carcinoma in situ of the cervix that was successfully treated or you are having tamoxifen or other drugs to stop breast cancer coming back
are pregnant

Trial design

The researchers need 2,748 women to take part. Some will have been through the menopause (postmenopausal) and some won’t (premenopausal).

Everyone taking part

Fills in a questionnaire asking about your symptoms
Gives a blood sample
Has a transvaginal and a tummy (abdominal) ultrasound scan

Specially trained radiographers will look at these scans in detail. You would most likely have these scans as part of your usual care. Some women might need to have an extra scan but the study team can tell you more if this applies to you.

ROCkeTS-GEN sub study
This is a sub-study for women who have been through menopause. It is for people who are 51 to 90 years old. There are other entry conditions and the team can tell you more about this.

In this part of the study you give a blood sample. The team plan to use the sample to look for small pieces of DNA from cancer cells (ctDNA Open a glossary item ).

Hospital visits

It is unlikely you will need any extra hospital visits as a result of taking part in this study, but this will depend on your local service.

If you don’t have surgery as part of your usual care, a research nurse will contact you at a routine hospital visit or at home a year after you joined the study to see how you are getting on. If you do have surgery as part of your usual care, the researchers will ask to link your details to national registries that store health information. This will help the researchers check if the blood tests we do now can predict any medical problems in the future.