A study to see if MRI scans can help to spot cancer in people with a condition called Li Fraumeni syndrome (SIGNIFY)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types

Status:

Closed

Phase:

Pilot

This study is looking to see if a whole body MRI scan would be useful in screening for cancers in people with a condition called Li Fraumeni syndrome (LFS).

More about this trial

Li Fraumeni syndrome  Open a glossary itemis a condition that runs in families. It is caused by a fault on a gene called TP53. Compared to the general population, people with this syndrome have a higher risk of getting breast cancersoft tissue sarcomasosteosarcoma, and adrenal gland Open a glossary item cancers.

Although there is a national breast screening programme for women with LFS, cancer can affect many different areas of the body, and there is no national whole body screening programme at the moment. So researchers in this study want to see how good MRI scans are at picking up cancers when they are used to scan the whole body, including the brain.

For this study, the researchers will recruit people who are known to have a TP53 gene fault.

So that they have a group of people to compare their results with, the researchers will also recruit people who do not have a fault on their TP53 gene. This group is called the control group. Everyone in the study will have a whole body MRI scan.

The aim of this study is to find out whether having an MRI scan of the whole body is useful in screening for cancer in people with Li Fraumeni Syndrome.

Please note the researchers have recruited enough people who have the TP53 gene fault but still need people who don't have the gene fault to join the control group.

Who can enter

You may be able to enter this study if

  • You have had genetic testing and been told that you carry a change to the TP53 gene
  • The TP53 gene change you have is known to significantly increase cancer risk

You can join the control group for this study if you

  • Are not related to someone with a known TP53 gene change
  • Have not had cancer
  • Haven’t got a parent, brother or sister who was diagnosed with cancer before they were 50

To enter the study, you must also be

You cannot enter this study if

  • You have a TP53 gene change and your genetics doctor is unsure whether it is likely to significantly increase your risk of cancer
  • You have had cancer (in the last 5 years if you carry a TP53 fault, or ever if you are in the control group), unless this was successfully treated carcinoma in situ of the cervix or non melanoma skin cancer
  • You have symptoms that may be cancer
  • You can’t have an MRI scan for any reason, such as having a fear of small spaces, or you have a pacemaker or some metal in your body

Trial design

This study is running at the Royal Marsden Hospital in Sutton, and at the Central Manchester Foundation Trust. But researchers are recruiting people from genetics services across England and Scotland, from a genetics database that lists people with the TP53 gene fault, and from users of Li Fraumeni support group websites who are interested in the study. They will recruit people who do not have Li Fraumeni syndrome (the control group) through newspaper adverts.

The pilot study will recruit 88 people into 2 groups. The group you join depends on whether or not you carry a TP53 gene fault.

Everyone taking part will have an MRI scan of their whole body. This scan will last between 40 to 50 minutes.

To have the MRI scan, you lie in a short tunnel inside the scanner. You will be able to ring a bell to communicate with the scanner staff at any time. If you do not feel able to complete the scan for any reason, you can stop it.

You fill out some questionnaires asking about how you feel about your health and situation, and the MRI scan. You complete these when you have your MRI scan, and then by post after

  • 12 weeks
  • 6 months
  • 1 year

The study team will pay for postage. You can phone them at any time for help with completing the questionnaires.

The team will contact your GP once a year for 2 years after your MRI scan to see how you are getting on.

Hospital visits

You visit the hospital 3 times, first to discuss the study, then have your MRI scan and for the results of the scan.

Side effects

During the scan, you may feel hot or anxious. But most people cope with it very well.

Whether you carry the gene change or not, there is a chance that the MRI scan may pick up an unexpected health problem. These are not likely to be related to cancer. If this happens, the team will talk to you about what they have found so that it can be looked into and treated if necessary.

The results of the questionnaire may show that you are at risk of depression. If this happens, the team would like to talk to you and your GP about this.

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 Ros Eeles

Supported by

Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Annabel Evans Memorial Fund
The Royal Marsden NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10304

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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