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NHS-Galleri Trial

A new test has been developed that can detect many types of cancer from a single blood sample, called the Galleri™ test.

About the NHS-Galleri Trial

The NHS-Galleri Trial is a research trial to see how well the new Galleri™ test works in the NHS. The aim is to see whether the test finds cancer earlier when combined with standard cancer testing in people who don’t have any symptoms of cancer.

Research like this is essential to ensure the NHS is offering the best possible options to treat people as early as possible and keep them healthy. The NHS-Galleri Trial is being organised by GRAIL Bio UK Ltd in partnership with NHS England and will be run by The Cancer Research UK and King’s College London Cancer Prevention Trials Unit, a team of cancer researchers and trial managers at King's College London (King’s).

Who is eligible to take part

The NHS-Galleri Trial is being run in several regions around England. The trial is looking to invite participants between the ages of 50 and 77 who have not been diagnosed with, or treated for, cancer in the past three years.

Potential participants will be identified by NHS Digital on behalf of the trial. NHS Digital is the national custodian of health and care data in England. We collect and hold some information from the patient records that health and social care providers collect and maintain. The data we hold is used to plan and improve health services, including medical research. Using this data, we can run an electronic search to find potential participants who meet the eligibility criteria set by the trial. Some patients may be identified and invited by their GP.

What the trial involves

The trial will ask you to come to a clinic on a mobile unit to give a blood sample and fill in some questionnaires. At that time, the trial will confirm that you fit the trial requirements and ask if you agree to take part – you will be able to ask any questions.

The trial will ask you to come to the mobile unit a total of 3 times over about 2 years. You can leave the trial at any time without giving a reason. The more people able to stay on the trial, the better the quality of the research.

Half the people in the trial will be in the ‘test group.’ This means that their blood sample will be tested using the Galleri™ test. The other half will be in a ‘control group’ and their blood will be safely stored but not tested with the Galleri™ test. The control group samples may be tested with the Galleri™ test in the future to see if there are any differences between people in the test group and the control group. You will not be told which group you were in even after the trial is finished.

Everyone will be asked if their samples can be stored and tested at a later date to help with research to further improve the Galleri™ test, and to help develop other tests and see how well they work. We would like you to agree to this, but it will be your choice.

If a cancer signal is found, you will be contacted, and arrangements will be made for you to have follow-up tests at your local hospital to see if you have cancer.

How your information is used

NHS Digital has been asked to identify potentially eligible participants and to invite them to join the NHS-Galleri Trial. We will use the data we hold to identify suitable people and to send them an invitation to participate in the trial. The data used will include name, date of birth, address, NHS number and information about cancer diagnosis. Your personal data will not be shared directly with the trial.

If you decide to take part in the trial, you will be asked to provide written consent to the trial at your first visit.

If you have requested that your NHS data is not shared for research and planning purposes (by registering a National Data Opt-out) then you will not receive an invitation for this trial.

The trial has requested that all potentially eligible participants be contacted once only. To manage the invitation process, we will need to keep the trial invitation list until six months after the trial recruitment in completed. This is to ensure that you are not invited again and that those who have told us that they do not want to be contacted, do not receive an invitation in the first place.

After that, all the information stored for the purpose of this trial will be deleted. You can find out more about your choices on how the NHS uses your data for research and planning.

We will use your data to produce summary reports to monitor recruitment into the trial (for example how many people were invited). These reports will not identify you personally.

The Health Research Authority has provided legal support to the NHS-Galleri Trial under section 251 of the National Health Service Act 2006 – this includes permission for NHS Digital to process data on behalf of the trial. This support provides the legal basis for suitable participants to be identified and invited to join the trial. This is following advice from the Confidentiality Advisory Group, an advisory body which provides independent expert advice on the use of confidential patient information without consent in England and Wales.

Your rights over your personal data

To read more about the health and care information NHS Digital collects, our legal basis for collecting this information and what choices and rights you have, see how we look after your health and care information, and our general transparency notice and the related GDPR register entry.

You can request not to take part

If you do not want to be invited to take part in the NHS-Galleri Trial, please fill in our online form or call our contact centre on 0300 303 5678.

If you've previously opted out of sharing your health data for planning and research purposes by submitting a National Data Opt-out, you do not need to take any action. You will not be invited to take part in this trial.

Further information

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Last edited: 6 August 2021 2:36 pm