A study looking at whether it is possible to test all women to find out their risk of developing ovarian cancer (PROMISE FS)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Pilot

This study looked at whether it is possible to use health information and a blood test to predict a woman's risk of developing ovarian cancer.  It was supported by Cancer Research UK.

The study was open for people to join in 2017, and the team published the results in 2020.

More about this trial

Some women have an increased risk of ovarian cancer because they have a change in a particular gene

When this study was done, we knew a change in these genes increased ovarian cancer risk: 

  • BRCA1
  • BRCA2
  • RAD51C
  • RAD51D 
  • BRIP1

Some women with a strong family history of ovarian cancer might be able to have genetic testing on the NHS. But not everyone with these gene changes knows their family history. Or has a relative who has had cancer. 

There are also other risk factors that might increase someone’s risk. There may be women who have a higher than usual risk of developing ovarian cancer, but who don’t know about it. 

Researchers wanted to see if they can predict someone’s risk of developing ovarian cancer using genetic risk factors and other risk factors. But first they needed to see if it’s possible to run this sort of study.

The main aims of this study were to find out:

  • if it’s possible to run a larger study looking at ovarian cancer risk 
  • what women think about the study
  • how women feel about finding out their risk of developing ovarian cancer

Summary of results

The study team found that it was possible to run a study looking at ovarian cancer risk.

Study design
This study was for women who had not:

The research team asked the women to decide whether they wanted to find out about their risk of developing ovarian cancer. They had developed an online decision tool, and there was a dedicated helpline for women to contact if they wanted to.

If they decided to go ahead, the women were then asked to:

  • give a blood sample to test for the 5 genes known to increase the risk of ovarian cancer, and some other common genetic changes 
  • complete questionnaires about their family history and other risk factors

After that they were asked to complete questionnaires about how they found the online tool and helpline service. And other questionnaires which asked them about whether deciding to go ahead had affected things such as:

  • their levels of anxiety, depression or distress
  • their quality of life
  • how worried they were about developing ovarian cancer or other cancers
  • whether they were pleased they made the decision to take part and find out their risk

Results
A total of 123 women joined this study. They were given written information about the study and used the online decision tool. These helped them decide whether they wanted to know more about their risk of developing ovarian cancer or not.

Out of the 123 women,105 decided to find out more about their risk of developing ovarian cancer.

The study team looked at people’s risk of developing ovarian cancer during their lifetime, for 101 people who took part. They found that:

  • 1 person had a high risk (10% chance or higher)
  • no one had a medium risk (between 5 and 10% chance)
  • 100 people had a low risk (less than 5% chance)

What people thought about the study
The research team asked people what they thought about the online decision tool. They found that:

  • 94 people were satisfied or very satisfied with the online tool
  • 80 people understood more about ovarian cancer
  • 90 people understood more about genetic testing for ovarian cancer

They also asked people how they felt after using the online decision tool:

  • 82 people felt reassured 
  • 16 people were worried 
  • 5 people were upset 

Just 13 people decided to call the helpline to help them decide whether to take part or not. Of these, 8 filled out a questionnaire about how they found it. All 8 were satisfied or very satisfied with the service.

The team asked the people who decided to find out more about their ovarian cancer risk whether they felt they had made the right decision.  They found that 75 out of 76 people who responded agreed that they had made the right decision.

Quality of life
The research team looked at how taking part in this study had affected people’s quality of life. 

They found that it didn’t have any negative impact and that:

  • there was no decrease in people’s quality of life
  • there was no increase in people’s level of anxiety, depression or distress
  • people worried less about cancer 

Conclusion
The study team concluded that it would be possible to use a blood test and health questionnaire to assess ovarian cancer risk in the general population. 

They found that doing this didn’t have a negative impact on people’s quality of life or psychological well being. People’s worry about ovarian cancer decreased with time.

The team suggest more work is done to find out more about how this would work with a larger number of women. They hope to run a larger study looking at several different genes. 

Where this information comes from    
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

Prof Ranjit Manchanda

Supported by

Cancer Research UK
Cedars Sinai Medical Centre
Harvard University
Queen Mary University of London
The Eve Appeal
University of Cambridge
University College London (UCL)
University of Manchester
University of New South Wales

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13282

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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