On July 18, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported that the NHS-Galleri trial successfully completed enrollment in just over 10 months (Press release, Grail, JUL 18, 2022, View Source [SID1234616739]). The trial, which is the largest-ever study of a multi-cancer early detection (MCED) test, has enrolled 140,000 healthy volunteers aged 50-77 from select regions throughout England who have not had a cancer diagnosis or undergone treatment for cancer in the last three years.

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The NHS-Galleri trial is a randomized, controlled clinical trial being conducted in England alongside standard cancer screening with diagnostic follow-up in the NHS’ clinical practice setting. Regions were selected to include areas of high cancer mortality, socioeconomic disparities, and ethnic diversity, using innovative methods to enroll a study population with participants traditionally less likely to take part in medical research. Participants visited one of 150 mobile clinics operating at locations around England and were recruited through activities including community group briefings, leaflet distribution in community settings, engagement through community champions, and targeted social media campaigns.

"Meeting the goal of enrolling 140,000 people is a significant achievement, allowing us to evaluate an unprecedented number of volunteers without symptoms of cancer and representing diverse socio-economic and ethnic populations," said Charles Swanton, MD, PhD, a cancer researcher and oncologist at University College London and the Francis Crick Institute, chief clinician at Cancer Research UK, and co-chief investigator of the study. "Whilst the first year of the trial may pick up cancers that have existed for some time, the second and third years provide the best opportunity to explore the expected benefits of picking up new cancers at an early stage when treatment is generally more successful. By screening participants annually over three years, we will be able to explore how MCED tests can be used alongside existing NHS screening programs."

The study’s aim is to determine if the Galleri test, alongside standard cancer screening, can find asymptomatic cancers at earlier stages than they are found in clinical care today. The study will assess absolute numbers of stage 3 and 4 cancers diagnosed following three annual Galleri tests. The first screen will aim to identify the prevalent cancers in the population, while the second and third screens will aim to identify cancers that have newly emerged.

"NHS-Galleri has set a new standard in the speed of set-up and recruitment to clinical trials," said Professor Peter Sasieni, Director of The Cancer Research UK & King’s College London Cancer Prevention Trials Unit and one of the trial’s lead investigators. "Previous trials of this magnitude would typically have taken five times as long. Accelerating research means that we will find out sooner whether new technology has a role in the control of cancer and, if it does, introducing it within the NHS quickly so that more people can benefit."

This trial supports the NHS Long Term Plan ambition to catch three quarters of cancers at an early stage, when they are less advanced, and treatment has a higher chance of being successful and potentially curative. Based on initial results, the NHS may roll out the test to an additional 1 million people.

"Today marks an important milestone in our long-term efforts to catch and treat cancer earlier," said Amanda Pritchard, chief executive at NHS. "We know that certain cancers are harder to detect and a late diagnosis can be devastating for patients and their families, and this trial means thousands could benefit from a diagnosis even before symptoms appear."

In a previous clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, many of which lack recommended screening tests today in the UK. Early clinical trials report that GRAIL’s Galleri test has a false positive rate under 1% and can predict where a cancer signal originated with 89% accuracy.

"We are so grateful for the public’s enthusiasm for this trial and to all those who have volunteered," said Sir Harpal Kumar, president at GRAIL Europe. "We are hopeful Galleri will work well alongside existing cancer screening in the UK, can provide clinicians with an accurate prediction of where the cancer is located in the body, and help the NHS reduce the number of cancers detected at a late stage."

The study is sponsored by GRAIL and is being run by The Cancer Research UK and King’s College London Cancer Prevention Trials Unit (UK), in collaboration with eight cancer alliances in England. The study design of the trial was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #TPS6606) in June 2022.

About NHS-Galleri Trial

For the prospective, blinded, randomized controlled trial, study participants will provide a blood sample during three annual visits to a mobile health clinic—at baseline, year 1 and year 2. After the first visit, participants are randomized 1:1 into either the intervention or control arm. Participants in the intervention arm will have their blood tested by the Galleri test. Blood samples from subjects in the control arm will not be tested immediately, but will be stored for potential future testing. If a cancer signal is detected for those in the intervention arm, research staff will explain the result and schedule an appointment for follow-up tests at an NHS hospital local to the participant. All participants in the study will be followed for cancer and other related outcomes via NHS databases and will be reminded to continue to have guideline-recommended cancer screenings.