# NHS-Galleri: design of the largest randomised trial of a multi-cancer blood test

Source: https://onco.cc/key-papers/paper-nhs-galleri-design-cancers-2022/  
OnCo record `paper-nhs-galleri-design-cancers-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

The 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.

The 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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: Cancers
- Year: 2022
- DOI: 10.3390/cancers14194818
- Authors: Neal RD, Johnson P, Clarke CA, et al.
- 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
- What it means: 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

## Sources

- DOI: https://doi.org/10.3390/cancers14194818
- NHS-Galleri trial site: https://www.nhs-galleri.org

## Connected records

- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/), [Early detection roadmap: organ screening → blood tests for many cancers](https://onco.cc/roadmaps/early-detection-roadmap/)
- ideas: [Let MCED trials read out on late-stage incidence, with mortality follow-up mandated](https://onco.cc/ideas/idea-prev-mced-stage-endpoint-surrogate/), [Registry-based randomised MCED trial: a million people, no study visits](https://onco.cc/ideas/idea-prev-mced-registry-randomised/)
- fronts: [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/)
- drugs: [Galleri](https://onco.cc/drugs/galleri/)
- terms: [Positive predictive value (PPV)](https://onco.cc/terms/ppv/), [Stage shift](https://onco.cc/terms/stage-shift/)
- trials: [NHS-Galleri](https://onco.cc/trials/nhs-galleri/), [PATHFINDER 2](https://onco.cc/trials/pathfinder-2/)
- bottlenecks: [Overdiagnosis and false alarms](https://onco.cc/bottlenecks/b-overdiagnosis/), [The hardest cancers are found late](https://onco.cc/bottlenecks/b-early-detection/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/)
- journals: [Cancers](https://onco.cc/journals/cancers-mdpi/)
- people: [Peter Sasieni](https://onco.cc/people/peter-sasieni/)
- key papers: [Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial](https://onco.cc/key-papers/paper-nhs-galleri-performance-nat-med-2026/)

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