A prospective, randomized, controlled trial to assess the performance and clinical utility of the Galleri® test for population screening in the UK when added to standard of care.
This is a trial in a large population in England to assess the performance and clinical utility of GRAIL’s multi-cancer early detection test when added to standard of care. Participants are randomized to either a test or control arm. The study teams remain blinded throughout the study. Participants who test positive will be referred for standard of care investigations and treatment in the National Health Service (NHS).
The study has enrolled approximately 140,000 people aged 50 to 77 who had not been diagnosed or treated for cancer in the three years prior to enrollment. Unless diagnosed with cancer, participants in both arms are returning for annual visits at approximately 12 and 24 months. All participants whether test positive, test negative or not tested will be followed for cancer and associated outcomes via linkage to NHS routine datasets.