{"entity":{"id":"paper-nhs-galleri-design-cancers-2022","kind":"paper","name":"NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test","aka":[],"tldr":"The NHS-Galleri design paper is the protocol for a 140,000-person randomised trial in England testing whether three annual Galleri blood tests reduce late-stage (III-IV) cancer diagnoses, the first MCED trial powered for a stage-shift endpoint.","summary":"NHS-Galleri (ISRCTN91431511) enrolled about 140,000 asymptomatic adults aged 50-77 through NHS England, randomised 1:1 to annual Galleri testing for three years with results returned, or to blood draws stored without testing. The design paper set out the primary endpoint of a reduction in stage III-IV cancer incidence between arms, with secondary endpoints including stage IV incidence, cancer-specific mortality and test performance.\n\nThe trial deliberately over-sampled deprived and ethnically diverse communities using mobile clinics. Results were reported in 2026; the trial record in this corpus tracks the primary and secondary outcomes and the regulatory response.\n\nThe design is important in its own right: it established stage shift as a pragmatic proxy endpoint for screening trials of multi-cancer tests, a choice that remains contested.","asOf":"2026-09-08","links":[{"label":"DOI","url":"https://doi.org/10.3390/cancers14194818"},{"label":"NHS-Galleri trial site","url":"https://www.nhs-galleri.org"}],"tags":[],"related":["early-detection-roadmap","idea-prev-mced-stage-endpoint-surrogate","idea-prev-mced-registry-randomised"],"cancers":[],"sections":["early-detection"],"technologies":["mced","liquid-biopsy"],"targets":[],"drugs":["galleri"],"companies":[],"institutions":[],"pathways":[],"terms":["stage-shift","ppv"],"trials":["nhs-galleri","pathfinder-2"],"people":[],"bottlenecks":["b-early-detection","b-trial-design","b-overdiagnosis"],"keyPapers":[],"journals":["cancers-mdpi"],"dependsOn":[],"notes":[],"journal":"Cancers","year":2022,"doi":"10.3390/cancers14194818","authors":"Neal RD, Johnson P, Clarke CA, et al.","paperType":"methods","findings":["About 140,000 participants randomised, recruited through mobile clinics across NHS regions in England","Primary endpoint: absolute reduction in stage III-IV cancers in the intervention arm; key secondary endpoint: stage IV incidence","Test results were not returned in the control arm, preserving blinding of the population and clinicians","Population enriched for deprived and minority communities, unusual for a screening trial"],"whatItMeans":"NHS-Galleri is the trial that will decide whether a blood test for many cancers at once should be offered by a health system. Its endpoint is a reduction in late-stage cancer rather than deaths, so even a positive result leaves the mortality question to be settled by longer follow-up.","caveats":["Stage shift is a surrogate: fewer late-stage cancers does not guarantee fewer deaths, and lead-time and overdiagnosis can distort it","Three annual rounds is short for detecting slow-growing cancers","A single commercial test; results may not generalise to other MCED assays","Sponsor involvement in design and analysis (GRAIL) was substantial"],"changedPractice":false,"participants":140000},"route":"/key-papers/paper-nhs-galleri-design-cancers-2022/","neighbours":{"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"early-detection-roadmap","kind":"roadmap","name":"Early detection roadmap: organ screening → blood tests for many cancers","route":"/roadmaps/early-detection-roadmap/"}],"idea":[{"id":"idea-prev-mced-stage-endpoint-surrogate","kind":"idea","name":"Let MCED trials read out on late-stage incidence, with mortality follow-up mandated","route":"/ideas/idea-prev-mced-stage-endpoint-surrogate/"},{"id":"idea-prev-mced-registry-randomised","kind":"idea","name":"Registry-based randomised MCED trial: a million people, no study visits","route":"/ideas/idea-prev-mced-registry-randomised/"}],"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"drug":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"}],"term":[{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"},{"id":"stage-shift","kind":"term","name":"Stage shift","route":"/terms/stage-shift/"}],"trial":[{"id":"nhs-galleri","kind":"trial","name":"NHS-Galleri","route":"/trials/nhs-galleri/"},{"id":"pathfinder-2","kind":"trial","name":"PATHFINDER 2","route":"/trials/pathfinder-2/"}],"bottleneck":[{"id":"b-overdiagnosis","kind":"bottleneck","name":"Overdiagnosis and false alarms","route":"/bottlenecks/b-overdiagnosis/"},{"id":"b-early-detection","kind":"bottleneck","name":"The hardest cancers are found late","route":"/bottlenecks/b-early-detection/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"}],"journal":[{"id":"cancers-mdpi","kind":"journal","name":"Cancers","route":"/journals/cancers-mdpi/"}],"person":[{"id":"peter-sasieni","kind":"person","name":"Peter Sasieni","route":"/people/peter-sasieni/"}],"paper":[{"id":"paper-nhs-galleri-performance-nat-med-2026","kind":"paper","name":"Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial","route":"/key-papers/paper-nhs-galleri-performance-nat-med-2026/"}]}}