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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.
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.
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.
Shares Registry-based randomised MCED trial: a million people, no study visits, PATHFINDER 2, Galleri, NHS-Galleri.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Positive predictive value (PPV).
Shares PATHFINDER 2, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, Galleri, NHS-Galleri.
Shares PATHFINDER 2, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, Galleri, NHS-Galleri.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).
Shares PATHFINDER 2, Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial, Galleri, NHS-Galleri.
Shares NHS-Galleri, Stage shift, The hardest cancers are found late, Trial design, endpoints and cost.
Shares PATHFINDER 2, Galleri, NHS-Galleri, Multi-cancer early detection (MCED).