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

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Other

This study was for women who have changes (mutations) in the BRCA1 or BRCA2 gene. This means they have an increased risk of developing certain cancers, including ovarian cancer.

This study was open for people to join in 2018 and 2019. The team published the results in 2022.

More about this trial

Genes are coded messages that tell cells how to behave. Some people have changes (mutations) in genes called BRCA1 and BRCA2. This increases their risk of developing some cancers, including ovarian cancer.

Doctors recommend that women with a BRCA1 or BRCA2 mutation have surgery to remove their ovaries and fallopian tubes. This can stop ovarian cancer from developing. 

But some women can’t have surgery because of other health problems. Or they may choose not to because they:

  • want to have children
  • don’t want to go through an early menopause 

These women remain at an increased risk of developing ovarian cancer. 

In this study, researchers looked at a test called the ROCA Test. ROCA stands for Risk of Ovarian Cancer Algorithm. It calculates a risk score for each woman using a combination of:

  • their CA-125 blood test results
  • their age
  • whether they have been through the menopause or not

The research team hoped it would be useful for women at high risk of ovarian cancer who don’t have surgery to remove their ovaries.

The main aim of this study was to find out whether the ROCA Test can be used within the NHS to find ovarian cancer earlier. And whether this might be cost effective for the health service.

Summary of results

Study design
This study was for women who:

  • had a BRCA1 or BRCA2 gene change (mutation)
  • didn’t want to have an operation to remove their ovaries
  • weren’t having any symptoms of ovarian cancer

The doctors assessed everyone’s risk of developing ovarian cancer using the ROCA Test. The women taking part all had the ROCA Test and were given 1 of 4 risk levels.

Normal risk - less than 1 person in 1,000 will have ovarian cancer. People in this group had another ROCA assessment 4 months later.

Mildly elevated risk – 1 person in every 501 to 1,000 people will have ovarian cancer. People in this group had another ROCA assessment 6 weeks later.

Moderately elevated risk – 1 person in every 34 to 500 people will have ovarian cancer. People in this group had another ROCA assessment and a vaginal ultrasound scan to check for signs of ovarian cancer.

Significantly elevated risk – 1 person (or more) in every 33 people will have ovarian cancer. People in this group were referred to a specialist doctor for more tests. They also had another ROCA assessment and a vaginal ultrasound scan. 

Results
A total of 767 women had at least one ROCA Test as part of this study. Following the results of the tests:

  • 104 women had a vaginal ultrasound scan
  • 22 women were referred to a specialist doctor
  • 8 women had surgery for possible ovarian cancer
  • 6 women were diagnosed with ovarian cancer

Another 2 women were diagnosed with ovarian cancer without having the ROCA Test.

The team looked at how accurate the ROCA Test was. 

They found that it can help identify nearly 9 out of 10 women (87%) who have ovarian cancer. This means a small proportion of women whose tests show they do not have cancer, actually do have cancer.

They also found that it can identify nearly all women (99.9%) who don’t have ovarian cancer. This means that hardly anyone who doesn’t have ovarian cancer will have test results that suggest they do have cancer. 

Cost
The research team looked at how much it costs to do ROCA surveillance testing and treat people with ovarian cancer.

Screening does cost money. But many of the cancers diagnosed are likely to be at an earlier stage. They may not need as major surgery as those diagnosed later. And they may not need expensive medicines often used to treat more advanced cancers. So screening could cost less overall. 

Conclusion
The research team concluded that it is possible to use the ROCA Test to detect ovarian cancer before it causes symptoms. This is for women who have a BRCA1 or BRCA2 gene change. 

Surgery to prevent ovarian cancer is still recommended for these women, but some women can’t have or don’t want surgery straight away. The team say using the ROCA Test in these women could save money. This is because cancers diagnosed by surveillance may not need as much treatment.

More detailed information
There is more information about this research in the reference below. 

Please note, this article is not in plain English. It has been written for health care professionals and researchers.

The avoiding late diagnosis of ovarian cancer (ALDO) project; a pilot national surveillance programme for women with pathogenic germline variants in BRCA1 and BRCA2
S Philpott and others
Journal of Medical Genetics, published online November 2022. 
doi: 10.1136/jmg-2022-108741

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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

Dr Adam Rosenthal

Supported by

Abcodia Ltd (now owned by GENinCode Plc)
University College London Hospitals NHS Foundation Trust
UCLH Cancer Collaborative
North Central London Cancer Alliance

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15881

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

Last reviewed:

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