Podkast: Å screene for kreft med én blodprøve

Tidsskriftet har vært i kontakt med Grail, og en talsperson for NHS-Galleri-studien uttaler følgende:

The NHS-Galleri trial (NCT05611632) is the first and largest randomised controlled trial of a multi-cancer early detection (MCED) blood test, involving over 140,000 participants in the UK. Following baseline blood collection, participants were randomised 1:1 to the intervention (blood tested by MCED test) or control (blood stored) arm. Only participants in the intervention arm with a cancer signal detected have results returned and are referred for urgent investigations and potential treatment. Remaining participants in both arms stay blinded and return for their next visit. Participants are encouraged to continue other NHS cancer screening programmes and seek help for new or unusual symptoms. The primary objective is to demonstrate a statistically significant reduction in stage III and IV cancers diagnosed in the intervention versus control arm 3-4 years after randomisation. Cancer-specific mortality will also be analysed after five years of follow up. 

The trial was never due to be published in 2024, nor has the timeline changed at any point. In accordance with the trial design, the primary outcome is measured over 3-4 years, with data collection running through summer 2025 and publication scheduled for 2026, after full analysis. Information about the trial, including the design and milestone timelines, are available in the public domain (1-3). 

The trial was designed with three annual screening rounds, intentionally chosen to robustly assess the primary end point. Modeling work assessing different MCED screening intervals also indicates that annual screening is associated with more favorable per-year diagnostic yield and mortality (4). 

Some confusion appears to stem from articles that have conflated the publication of trial results with an interim NHS England decision about a potential implementation pilot. The NHS pilot - a large-scale feasibility project, organised separately from the trial - was not launched following a decision to await final trial results (5, 6). NHS England reiterated its support of the trial and analysis timeline: “The NHS-Galleri trial was designed with three consecutive years of screening, and it is vital to evaluate the primary objective and endpoints at the end of the study in 2026.”(6)

References

1. Neal RD, Johnson P, Clarke CA, Hamilton SA, Zhang N, Kumar H et al. Cell-Free DNA-Based Multi-Cancer Early Detection Test in an Asymptomatic Screening Population (NHS-Galleri): Design of a Pragmatic, Prospective Randomised Controlled Trial. Cancers 2022; Oct 1;14(19): 4818.
2. Swanton C, Bachtiar V, Mathews C, Brentnall AR, Lowenhoff I, Waller J et al. NHS-Galleri trial: Enriched enrolment approaches and sociodemographic characteristics of enrolled participants. Clin Trials 2025; 22(2): 227–38. https://doi.org/10.1177/17407745241302477
3. NHS-Galleri Trial. About the trial. https://www.nhs-galleri.org/about-the-trial Retrieved May 2, 2025.
4. Sasieni P, Clarke CA, Hubbell E. 1135P Impact of MCED screening interval on reduction in late-stage cancer diagnosis and mortality. Ann Oncol. 2021; Sep 1;32: S925. https://www.annalsofoncology.org/article/S0923-7534(21)03006-4/fulltext Retrieved May 2, 2025.
5. Kumar H. GRAIL Update on the Accelerated Implementation of Multi-Cancer Early Detection Technology by NHS England. GRAIL 2024. https://grail.com/stories/grail-update-on-the-accelerated-implementation-of-multi-cancer-early-detection-technology-by-nhs-england/ Retrieved May 2, 2025.
6. Johnson P. An update on the ongoing NHS-Galleri trial. NHS England May 29 2024. https://www.england.nhs.uk/blog/an-update-on-the-ongoing-nhs-galleri-trial/ Retrieved May 2, 2025.