{"entity":{"id":"nhs-galleri","kind":"trial","name":"NHS-Galleri","aka":["NHS-Galleri trial"],"tldr":"The largest cancer screening trial ever run, testing whether a multi-cancer blood test reduces late-stage diagnoses; it reports that it did not, and its test-performance paper appeared in Nature Medicine on 22 September 2026.","summary":"NHS-Galleri (ISRCTN91431511; ClinicalTrials.gov NCT05611632) randomised 142,250 people aged 50 to 77 in England 1:1 to GRAIL's Galleri multi-cancer early detection (MCED) test added to usual NHS care, or to control, with three annual screening rounds; positive results were referred to NHS standard-of-care diagnostic pathways informed by the predicted cancer signal origin. The primary endpoint was a reduction in the incidence of stage III/IV cancer diagnoses in the intervention arm versus control, tested first in 12 prespecified cancer types (lung, head and neck, colorectal, pancreas, myeloma or plasma cell neoplasm, liver or bile duct, stomach, oesophagus, anus, lymphoma, ovary and bladder).\n\nThe test-performance paper in Nature Medicine (22 September 2026) states that the primary endpoint was not met and was reported elsewhere; no peer-reviewed primary-endpoint paper was indexed on Europe PMC by 23 September 2026, so the primary result rests on that statement and on GRAIL's 30 May 2026 release. The paper's own figures, for the intervention arm: positive results in 1.03, 0.80 and 0.90 percent of participants in rounds 1 to 3; 937 MCED-detected primary cancers in aggregate; cancer detection rates 0.60, 0.40 and 0.41 percent; positive predictive values 58.0, 50.4 and 45.8 percent; negative predictive values 98.98, 98.90 and 98.86 percent; specificity 99.50 to 99.60 percent; episode sensitivity 26.7 to 37.2 percent for all cancers and 47.6 to 63.4 percent for the 12 prespecified types.\n\nThe registry lists the trial as active, not recruiting, with 142,318 participants, primary completion on 12 June 2026 and study completion in January 2031 for longer follow-up including cancer-specific mortality. The data feed GRAIL's FDA premarket approval application and the advisory committee of 23 September 2026.","status":"active","asOf":"2026-09-04","links":[{"label":"ISRCTN91431511","url":"https://www.isrctn.com/ISRCTN91431511"},{"label":"ClinicalTrials.gov NCT05611632","url":"https://clinicaltrials.gov/study/NCT05611632"},{"label":"Nature Medicine 2026: test performance across three rounds","url":"https://doi.org/10.1038/s41591-026-04652-8"},{"label":"NHS-Galleri","url":"https://www.nhs-galleri.org"}],"tags":[],"related":[],"cancers":["lung-cancer","head-and-neck","colorectal","pancreatic","multiple-myeloma","hcc","cholangiocarcinoma","gastric","esophageal","anal","hodgkin-lymphoma","non-hodgkin-lymphoma","ovarian","urothelial"],"sections":[],"technologies":["mced","cfdna-methylation-testing","methylation-profiling"],"targets":[],"drugs":["galleri"],"companies":["grail"],"institutions":[],"pathways":[],"terms":["stage-shift","ppv","screening"],"trials":[],"people":["peter-sasieni","charles-swanton","peter-johnson","eric-klein","deb-schrag"],"bottlenecks":[],"keyPapers":["paper-nhs-galleri-performance-nat-med-2026","paper-nhs-galleri-design-cancers-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05611632","phase":"3","setting":"142,250 asymptomatic adults aged 50 to 77 in England, randomised 1:1 to three annual rounds of the Galleri multi-cancer early detection blood test added to usual NHS care, or to blood draws stored without results","sponsor":"GRAIL, Inc. (lead sponsor on the registry) with NHS England and the Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London","started":"2021-08-31","startedType":"actual","yearReported":2026,"enrolled":142250,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT05611632 and ISRCTN91431511 list 142,318 participants (actual); the Nature Medicine test-performance paper reports 142,250 participants randomised 1:1.","outcomes":[{"endpoint":"Stage III to IV incidence, 12 prespecified cancers (primary)","primary":true,"arms":[{"name":"Galleri + usual NHS care","note":"Not met, per the Nature Medicine test-performance paper (22 September 2026), which states the primary endpoint was not met and reported elsewhere; no peer-reviewed primary-endpoint paper was on Europe PMC by 23 September 2026, so no figures are recorded here."},{"name":"Usual NHS care"}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Positive test results by screening round","unit":"%","arms":[{"name":"Round 1","n":70325,"value":1.03,"note":"722, 518 and 561 positive results among evaluable intervention-arm participants"},{"name":"Round 2","n":64498,"value":0.8},{"name":"Round 3","n":62323,"value":0.9}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Cancer detection rate by screening round","unit":"%","arms":[{"name":"Round 1","n":70325,"value":0.6,"note":"937 participants had MCED-detected primary cancers across the three rounds"},{"name":"Round 2","n":64498,"value":0.4},{"name":"Round 3","n":62323,"value":0.41}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Positive predictive value by screening round","unit":"%","arms":[{"name":"Round 1","n":722,"value":58,"note":"419/722, 261/518 and 257/561"},{"name":"Round 2","n":518,"value":50.4},{"name":"Round 3","n":561,"value":45.8}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Negative predictive value by screening round","unit":"%","arms":[{"name":"Round 1","n":69603,"value":98.98,"note":"68,895/69,603, 63,278/63,980 and 61,058/61,762"},{"name":"Round 2","n":63980,"value":98.9},{"name":"Round 3","n":61762,"value":98.86}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Specificity, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":99.5,"note":"The abstract gives the range across rounds 1 to 3, not per-round values"},{"name":"Highest round","value":99.6}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Episode sensitivity, all cancers, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":26.7,"note":"Range across rounds 1 to 3 as given in the abstract"},{"name":"Highest round","value":37.2}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Episode sensitivity, 12 prespecified cancer types, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":47.6,"note":"Range across rounds 1 to 3 as given in the abstract"},{"name":"Highest round","value":63.4}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Cancer signal origin accuracy, range across rounds","unit":"%","arms":[{"name":"Lowest round","value":91.1},{"name":"Highest round","value":93.6}],"source":"https://doi.org/10.1038/s41591-026-04652-8"},{"endpoint":"Relative reduction in stage IV diagnoses, rounds 2 and 3","unit":"%","arms":[{"name":"Round 2","value":22,"note":"Relative reduction versus control in the 12 prespecified cancers, from GRAIL's release of 30 May 2026; not in the Nature Medicine paper"},{"name":"Round 3","value":26}],"source":"https://grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/"},{"endpoint":"Relative reduction in diagnosis through emergency presentation","unit":"%","arms":[{"name":"Galleri + standard screening","value":25,"note":"From GRAIL's release of 30 May 2026; not in the Nature Medicine paper"}],"source":"https://grail.com/press-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting/"}],"replication":"The only randomised MCED trial; PATHFINDER 2 (single-arm) is consistent on detection rate and positive predictive value. The primary-endpoint paper had not appeared by 23 September 2026 and mortality follow-up runs to January 2031 on the registry."},"route":"/trials/nhs-galleri/","neighbours":{"cancer":[{"id":"anal","kind":"cancer","name":"Anal cancer (squamous cell carcinoma)","route":"/cancers/anal/"},{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"hodgkin-lymphoma","kind":"cancer","name":"Hodgkin lymphoma","route":"/cancers/hodgkin-lymphoma/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cfdna-methylation-testing","kind":"technology","name":"Cell-free DNA methylation tests","route":"/technologies/cfdna-methylation-testing/"},{"id":"methylation-profiling","kind":"technology","name":"DNA methylation profiling","route":"/technologies/methylation-profiling/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"drug":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"}],"company":[{"id":"grail","kind":"company","name":"GRAIL","route":"/companies/grail/"}],"term":[{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"},{"id":"stage-shift","kind":"term","name":"Stage shift","route":"/terms/stage-shift/"}],"person":[{"id":"charles-swanton","kind":"person","name":"Charles Swanton","route":"/people/charles-swanton/"},{"id":"deb-schrag","kind":"person","name":"Deborah Schrag","route":"/people/deb-schrag/"},{"id":"eric-klein","kind":"person","name":"Eric A. Klein","route":"/people/eric-klein/"},{"id":"peter-johnson","kind":"person","name":"Peter Johnson","route":"/people/peter-johnson/"},{"id":"peter-sasieni","kind":"person","name":"Peter Sasieni","route":"/people/peter-sasieni/"}],"paper":[{"id":"paper-nhs-galleri-design-cancers-2022","kind":"paper","name":"NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test","route":"/key-papers/paper-nhs-galleri-design-cancers-2022/"},{"id":"paper-pathfinder-lancet-2023","kind":"paper","name":"PATHFINDER: the first prospective test of a multi-cancer blood test in people without symptoms","route":"/key-papers/paper-pathfinder-lancet-2023/"},{"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/"}],"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/"}],"bottleneck":[{"id":"b-early-detection","kind":"bottleneck","name":"The hardest cancers are found late","route":"/bottlenecks/b-early-detection/"}],"idea":[{"id":"idea-moon-population-interception","kind":"idea","name":"A whole-population cancer interception programme: risk-stratify every adult, detect and intercept early","route":"/ideas/idea-moon-population-interception/"},{"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-open-stage-shift-microsimulation","kind":"idea","name":"Open-source models that translate stage shift into lives saved, for every cancer","route":"/ideas/idea-prev-open-stage-shift-microsimulation/"},{"id":"idea-prev-mced-change-control-plan","kind":"idea","name":"Pre-agreed update rules so an MCED test is not obsolete when its trial reads out","route":"/ideas/idea-prev-mced-change-control-plan/"}],"institution":[{"id":"guys-st-thomas","kind":"institution","name":"Guy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer Centre","route":"/institutions/guys-st-thomas/"}],"trial":[{"id":"vanguard-study","kind":"trial","name":"Vanguard Study (NCI Cancer Screening Research Network)","route":"/trials/vanguard-study/"}]}}