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

Cancer type:

Ovarian cancer

Status:

Open

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 Open a glossary item)
  • 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).

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. There is a sub study called ROCkeTS-GEN that you may be able to join if you have been through menopause. 

 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.

Side effects

The researchers don’t expect there to be any side effects as a result of taking part in this study.

Location

Brighton
Cardiff
Durham
Gateshead
Huntingdon
Liverpool
London
Middlesbrough
Norfolk
Northampton
Nottingham
Redhill
Southampton

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

Professor Sudha Sundar

Supported by

NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
University of Birmingham

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12654

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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