Active not recruitingNAINTERVENTIONAL

Does Screening With the Galleri Test in the NHS Reduce the Likelihood of a Late-stage Cancer Diagnosis in an Asymptomatic Population? A Randomised Clinical Trial

This study is investigating a new blood test, called the Galleri test, that can look for potential signs of many different types of cancer. The main goal is to find out if using this test alongside standard NHS cancer checks can help detect cancers earlier in people who don't yet have symptoms. Finding cancer at an early stage usually means it's easier to treat. Around 140,000 people aged 50-77 are taking part. Some will have the Galleri test, and others will continue with their usual NHS care. Researchers will follow everyone for about three years to see if the Galleri test leads to cancers being found sooner.

At a glance

Status

Active not recruiting

Phase

Sponsor

GRAIL, Inc.

Enrolment target

142,318

Start

31 Aug 2021

Estimated completion

01 Jul 2030

Cancer

What is this study about?

This study is exploring whether a new blood test, called the Galleri test, can help the NHS find cancers earlier. This test looks for tiny clues in your blood that might suggest cancer is present, and it's designed to detect many different types of cancer, not just one. The idea is that if cancer can be found at an early stage, before symptoms even start, it's often much simpler and more successful to treat.

The study wants to see if adding the Galleri test to the care people already receive from the NHS can make a real difference. They're comparing two groups of people: one group will have the new blood test, and the other will continue with their usual NHS health checks. By doing this, researchers can understand if the Galleri test actually helps reduce the number of people who are diagnosed with cancer at a later, potentially harder-to-treat stage.

About 140,000 people are taking part. They will be followed closely for about three years to see how things progress regarding cancer diagnoses. This research could help inform how cancer screening might be done in the future across the UK.

Key takeaways

This study explores a new blood test (Galleri) for early cancer detection.
It aims to find out if the test reduces late-stage cancer diagnoses for people aged 50-77.
Participants were either offered the test or continued with standard NHS care.
The study follows people for about three years to track cancer diagnoses.
Finding cancer earlier can often lead to more successful treatment.

Who may be eligible?

To join this study, you needed to be between 50 and 77 years old when recruitment happened. You also had to be able to understand the study and give your own written permission to take part.

You wouldn't have been able to join if you had cancer in the last three years (except for some non-melanoma skin cancers or certain prostate cancers). People currently being checked for suspected cancer, or those receiving palliative care, were also not eligible. This study is for people who don't have cancer symptoms, to see if we can find it early.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 77 years old?
Have you had any type of cancer diagnosis in the last three years (excluding some skin or prostate cancers)?
Are you currently being investigated for suspected cancer by the NHS?
Are you receiving care specifically for end-of-life comfort (palliative care)?

Answer every question to see your result.

What does participation involve?

If you took part in this study, you were placed into one of two groups. In one group, you would have had blood samples taken for the Galleri test. If this test showed a possible sign of cancer, you would have been contacted by a nurse from the study and referred to the NHS for further checks without delay. In the other group, blood samples were collected and saved for later, but you didn't receive any test results; you continued with your usual NHS care.

Everyone in the study, whether they had the test or not, was asked to come for follow-up visits once a year for about two years. The researchers will also check NHS records over about three years to see if anyone in the study was diagnosed with cancer and at what stage.

Potential risks and benefits

Taking part could offer an potential benefit if you were in the group that received the Galleri test and it helped find a cancer earlier than it otherwise would have been detected. However, it's important to remember that this test is new, and we don't yet know if it definitely reduces advanced cancer diagnoses for everyone. There are no direct physical risks from the blood test itself, beyond the usual minor discomfort of a blood draw. You always have the right to withdraw from the study at any time without affecting your NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

EMS Healthcare Ltd
Verified postcode
Macclesfield, United Kingdom

Common questions

What is the Galleri test?

It's a new blood test designed to look for early signs of many different types of cancer in people who don't have symptoms.

Who is eligible for this study?

The study included people aged 50-77 who had not had certain cancers recently and were not currently being investigated for suspected cancer.

What happens if the Galleri test finds something?

If your test suggested a possible sign of cancer, a study nurse would contact you, and you would be referred to the NHS for urgent further checks.

Will I get my test results if I take part?

Only participants whose Galleri test showed a possible sign of cancer were contacted with their results and referred for further checks. Others in the 'control' group had blood samples saved but didn't receive results.

How long does the study last?

Participants were actively followed for about three years from when they joined, including annual visits for roughly two years.