A study looking at ovarian cancer screening for women at high risk - The United Kingdom Familial Ovarian Cancer Screening Study (UK FOCSS)

Cancer type:

Breast cancer
Ovarian cancer

Status:

Results

Phase:

Other

This study looked at screening women who are at a high risk of developing ovarian cancer. This may be because they have a family history of ovarian cancer or breast cancer, or both. Or they (or a family member) have a genetic change known to increase the risk of ovarian cancer, such as BRCA 1 or BRCA 2. This trial was supported by Cancer Research UK.

More about this trial

When we talk about ovarian cancer in this summary we mean ovarian cancer, fallopian tube cancer or primary peritoneal cancer. All three have similar risk factors, symptoms and treatments.

Over 7,000 women are diagnosed with ovarian cancer in the UK every year. We know that women who have 2 or more close relatives with ovarian cancer or breast cancer may have a higher risk of developing ovarian cancer themselves.

Some women at high risk of developing ovarian cancer have screening. This is because they prefer not to have their ovaries and fallopian tubes removed to prevent cancer. But we don't know yet if screening is helpful or not.

The aim of this trial was to find out whether screening tests can pick up ovarian cancer at an early stage, before it causes symptoms and when treatment is more likely to be successful.

Summary of results

Part 1
Part 1 of this trial recruited 3,563 women between 2002 and 2008. They had an ultrasound scan and a CA125 blood test once a year. The results showed that 27 women were diagnosed with ovarian cancer within a year of their last screening test, and of these:

Another 10 women were diagnosed more than a year after their last screening test, and of these:

  • 1 woman (10%) was diagnosed with stage 1 cancer
  • 9 women (90%) were diagnosed with stage 3 or 4 cancer

The research team found that the gap between screening tests made a difference to the stage of cancer at diagnosis. The results showed that women who had longer than a year between screening tests were more likely to be diagnosed with a more advanced cancer.

The research team thought it may be better to do screening tests more often, so they set up part 2 of the trial in 2007 to try and find out.

Part 2
Part 2 of this trial recruited 4,348 women between 2007 and 2012. This included 2,362 women who had already been in part 1. The women in part 2 had a CA125 blood test every 4 months, and an ultrasound scan once a year.

The CA125 test results were analysed using a computer program, rather than being analysed in the usual way. This is called the Risk of Ovarian Cancer Algorithm (ROCA) and is a more accurate way of using CA125 to detect ovarian cancer.

The results showed that 13 women were diagnosed with cancer because of the results of their screening tests. Of these 13 women:

  • 5 women (38%) were diagnosed with stage 1 or 2 cancer
  • 8  women (62%) were diagnosed with stage 3 cancer
  • no women were diagnosed with stage 4 cancer
  • 12 women (92%) had their cancer completely removed with surgery
  • 1 woman (8%) had chemotherapy before surgery

Another 6 women were diagnosed less than a year after their last screening test. They were diagnosed because they had an operation to remove their ovaries and fallopian tubes. Of these 6 women:

  • 5 women (83%) were diagnosed with stage 1 or 2 cancer
  • 1 women (17%) was diagnosed with stage 3 cancer
  • no women were diagnosed with stage 4 cancer
  • all of the women had their cancer completely removed with surgery

A further 18 women were diagnosed with cancer more than a year after their last screening test as part of this trial. Of these 18 women:

  • 1 woman (5%) was diagnosed with stage 1 cancer
  • 14 women (78%) were diagnosed with stage 3 cancer
  • 3 women (17%) were diagnosed with stage 4 cancer
  • 13 women (72%) had their cancer completely removed with surgery
  • 7 women (44%) had chemotherapy before surgery

When the trial team analysed the results in 2016, 3 of the 37 women diagnosed with cancer in part 2 of the trial had died. Because this number is so small, they are unable to say for sure if diagnosing ovarian cancer earlier will help women live longer.

The trial team concluded that screening high risk women can pick up ovarian cancer at an earlier stage. But they are not able to say if this would affect how long these women live for.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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 Ian Jacobs

Supported by

Cancer Research UK
NHS Research and Development
NIHR Clinical Research Network: Cancer
National Institutes of Health (NIH)
The Eve Appeal

Other information

This is Cancer Research UK trial number CRUK/00/005.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

1083

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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