A trial looking at a new blood test to screen for cancer (NHS Galleri Trial)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a new blood test called the Galleri® test to see if it can detect cancer at an early stage. And to see if the test can be used alongside current UK screening programmes.
More about this trial
When doctors find cancer at an early stage, there is a better chance of treating it with the aim to cure. Researchers are looking for new ways to detect cancer early.
The Galleri test is a blood test. A previous study shows that it can detect over 50 different cancer types. Cancer can release small bits of 
into the blood. This is called cell free DNA or cfDNA. The test looks for these.
In this study you give 3 blood samples over a period of 2 years. Half of the people in the trial will be in the test group. Their blood samples will be tested with the Galleri test right away. Half will be in the control group. Their blood samples will be stored and may be tested in the future, but the results will not be shared.
If you are in the test group the team will refer you to a specialist doctor at your local hospital should the test detect a possibility of cancer.
The aim of this test is to find out how good the Galleri test is at detecting cancer early in the NHS.
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if you are at least 50 years old and no older than 77 years of age and can give informed consent.
Who can’t take part
You cannot join this trial if any of these apply. You:
- had cancer within the past 3 years. This is apart from
non melanoma skin cancer and early prostate cancer that your doctor is not actively treating but is watching (active surveillance). - had treatment for cancer within the past 3 years. This includes hormone therapy to reduce the risk of your cancer coming back after your main treatment. For example after surgery to remove prostate cancer or breast cancer.
- are taking medication that kills cells or that interferes with DNA. Your doctor will know if you are having these types of medication.
- have been referred to a 2 week wait clinic to see if you have cancer or are having other tests because you might have cancer
- are having
palliative care
Trial design
The trial team are asking NHS Digital and a small number of GPs to search for people who might be able to take part.
If you live in one of 8 areas of England where the trial is running you may be sent an invitation to join the trial. The trial needs 140,000 people to take part.
If you get an invitation you go online or call a freephone number to:
- confirm your interest
- check that you are the right age for the study
- book an appointment to see a member of the trial team
To take part you will be given an appointment at a mobile clinic. The mobile clinic will be at a location close to where you live. At the clinic you will watch a video about the trial and the Galleri test. Then a member of the trial team will answer any questions you might have.
You will be asked to fill in a and a questionnaire about your general health. You will then have a blood test.
This is a randomised blinded trial. Half of the people in the trial will be in the test group. Their blood samples will be tested with the Galleri test right away. Half will be in the control group. Their blood samples will be stored and may be tested in the future, but the results will not be shared.
Neither you nor the person taking the blood can choose whether your blood is tested using the Galleri test or not. Nor will either of you know at the time which group you are in.
You have a 1 in 2 chance (50%) of having your blood tested.
You go back to the mobile clinic for another blood sample at:
- 12 months
- 24 months
What happens for people in the Galleri test group?
Your blood is tested for signals that might mean you have cancer. A positive test doesn’t necessarily mean you have cancer or might develop cancer.
If there is a signal for cancer
A research nurse from the trial team will phone people whose test says there is a cancer signal in their blood. If you get a phone call about your test result, it doesn’t mean you have cancer. It means that you will have some follow up tests in a local hospital. You then receive a letter confirming this and a questionnaire.
If the trial team phone you, they will explain the result. They will also book you an appointment to have some follow up tests at your local NHS hospital. They do this as soon as possible, ideally with you during the phone call. The trial team will let your GP know about the test result.
The team at the hospital will decide on any tests or scans you might have and will discuss this with you.
If they find a cancer, your specialist doctor at the hospital will talk to you about treatment. You stop taking part in this trial.
If there is no sign of cancer you continue as part of the trial.
If there is no signal for cancer or you are in the group whose blood wasn’t tested
You receive a letter from the trial team confirming that they have been sent your blood sample. This letter is the same:
- for people that had a test that didn’t find a cancer signal and
- for people whose blood wasn’t tested at all
You won’t know if your blood was tested or not. It is very important that you continue to have other cancer screening when invited. You should contact your doctor if you notice a change that isn't normal for you, or if you have any possible signs and symptoms of cancer.
For those whose blood isn’t tested straight away
The team asks for your permission to store your blood samples.
They might use the Galleri test on your samples in the future, but you won’t find out what the results are.
This is to help them understand what happens to people in both groups.
Questionnaires
You fill in questionnaires when you join the trial and at set times during the trial. This is to find out about your general health and feelings about the test.
Every time you have an appointment for a blood sample you receive a £10 voucher as a thank you for your time.
Follow up
The trial team will use your name, NHS number, postcode and date of birth to check your health status from various NHS records. This may include information about you collected and managed by the NHS, the National Disease Registration Service (NDRS), and the Office of National Statistics (ONS).
They may do this for up to 10 years after your third blood test. They may keep this information for up to 20 years. This data can’t be linked directly to you. You can withdraw from this data transfer at any time.
Hospital visits
You go to a mobile clinic 3 times for the team to take a blood sample. You would only go to a hospital if the test detects a cancer signal and you need follow up tests.
Side effects
Giving a blood sample is generally a very safe procedure. After the blood sample you might:
- feel some pain where they took the sample
- have some bleeding or bruising
- feel a bit lightheaded
If the test says there is a cancer signal, this might make you feel anxious or distressed. The Galleri test is not perfect and can give a wrong result. If the test finds a cancer signal and no cancer is found by the specialist doctor, you may have had follow up tests that were not needed. Those follow up tests can have their own side effects. Your doctor will talk to you about these before you agree to have the tests.
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.
Chief Investigator
Professor Charles Swanton
Professor Richard Neal
Supported by
National Health Service (NHS) England
GRAIL, Bio UK Ltd.
The Cancer Research UK & King’s College London Cancer Prevention Trials Unit
Other information
You can read more about this trial on the NHS Galleri trial website.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
