GRAIL

Introduction

Diagnosing cancer early can increase the chance of successful treatment and patient outcomes. Improving the proportion of cancers diagnosed at an early stage is one of the aims of the NHS long term plan.

The Galleri® test is a multi-cancer early detection (MCED) blood test that aims to detect cancer at an early stage, before symptoms appear. The test looks at DNA in the blood to see if any of it may have come from cancer cells. It does this by looking for specific methylation patterns in circulating cell-free DNA that is released by cancer cells into the bloodstream. The Galleri test can detect signals released by multiple types of cancers and predict the tissue type or organ that the cancer signal originated from, through a single blood test. The Galleri test was developed by researchers at GRAIL Inc in the US.

There are currently three clinical trials in England assessing the effectiveness of the Galleri test in detecting cancer at an early stage: the NHS Galleri trial, the SUMMIT study, and the SYMPLFY study. The National Disease Registration Service (NDRS) provides routinely collected healthcare data to support the assessment of these trial outcomes.

The NHS-Galleri Trial

The NHS-Galleri trial (NCT05611632) is a randomised controlled trial (RCT) of 140,000 participants being conducted in the NHS in England. The aim of the trial is to assess the clinical utility of the Galleri test to detect cancer early in a population of people who don’t have symptoms, when used alongside existing NHS cancer screening programmes. The trial is run by the Cancer Research UK & Queen Mary University London Cancer Prevention Trials Unit.

The SUMMIT study

The SUMMIT study (NCT03934866) is a prospective cohort study which aims to evaluate the effectiveness of the Galleri test to detect cancer early in individuals who are at high risk of developing lung cancer due to a significant smoking history. The study is a collaboration between University College London (UCL), University College London Hospitals (UCLH) and GRAIL, and has recruited 13,000 participants across North Central and East London.

The SYMPLIFY study

The SYMPLIFY study was run by the University of Oxford and used the Galleri test to assess around 6,000 patients in England and Wales who were on a rapid referral diagnostic pathway because they had symptoms that might be due to cancer. The aim of the study was to assess how well the Galleri test worked in patients with potential cancer symptoms. Results for the SYMPLIFY study were published in 2023.

NDRS data provision

As the data partner for the trials, NDRS provides data for consented trial participants from routinely collected cancer data and other healthcare data sets.

Outputs

Results from the SYMPLIFY study were published in 2023.

A paper on the validity and timelines of cancer diagnosis data collected during the SYMPLIFY study.