{"id":19930,"date":"2022-10-12T13:46:11","date_gmt":"2022-10-12T12:46:11","guid":{"rendered":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/?p=19930"},"modified":"2022-10-12T13:46:11","modified_gmt":"2022-10-12T12:46:11","slug":"nhs-galleri-trial-briefing-for-primary-and-secondary-care-clinicians-20222023","status":"publish","type":"post","link":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/practice-news\/nhs-galleri-trial-briefing-for-primary-and-secondary-care-clinicians-20222023\/","title":{"rendered":"NHS-Galleri Trial Briefing for Primary and Secondary Care Clinicians 2022\/2023"},"content":{"rendered":"

Clinicians’ briefing produced by GRAIL, Cancer Research UK and King’s College London – September 2022<\/h2>\n

<\/h4>\n

Purpose<\/span><\/h3>\n

This briefing is to update primary and secondary care clinicians about the NHS-Galleri trial as it
\nmoves into its second operational year.<\/p>\n

Progress to date<\/span><\/h3>\n

The NHS-Galleri trial is a prospective, Randomised Controlled Trial (RCT) to assess the
\nperformance and clinical utility of a multi-cancer early detection test (Galleri\u00ae) for population
\nscreening in the United Kingdom (UK) when added to standard of care.<\/p>\n

The trial is designed to establish if screening with the Galleri test reduces the incidence of late stage cancer when used in an asymptomatic population in combination with existing NHS cancer screening programmes.<\/p>\n

Between August 2021 and July 2022 the NHS-Galleri trial successfully enrolled over 140,000
\nvolunteers from many different socio-economic and ethnic backgrounds across eight Cancer
\nAlliances in England.<\/p>\n

Those taking part were aged 50 to 77 years old at the point of enrolling onto the trial and had
\nnot been diagnosed or treated for invasive cancer in the last three years.<\/p>\n

In its first year, a small proportion of trial participants who received a \u2018Cancer Signal Detected\u2019
\nresult were referred to NHS urgent suspected cancer referral pathways (two-week wait) to
\ninvestigate a potential cancer diagnosis.<\/p>\n

Continuation of the trial in 2022\/2023<\/span><\/h3>\n

Over a one-year period starting in August 2022, participants will be invited to return to a local
\nmobile clinic for their second (12 month) appointment where they will be asked to give another
\nblood sample. Participants who have had a cancer diagnosis since their last visit do not need to
\nreturn for another blood test but will remain in the study and their data will be followed up.
\nParticipants without a cancer diagnosis will be asked to come back a third time, around one year
\nafter their second appointment for their 24 month appointment.<\/p>\n

There is very little data on repeat screening with the Galleri test and these next trial
\nappointments will help to establish the optimal screening interval. While the first year of the
\ntrial may pick up cancers that have existed for some time, the second and third years provide
\nthe best opportunity to explore the expected benefits of picking up new cancers at an early
\nstage when treatment is generally more successful.<\/p>\n

Vision for the future<\/span><\/h3>\n

The Galleri blood test, if successful in the context of NHS screening, could play a major part in
\nachieving the NHS Long Term Plan ambition to catch three quarters of cancers at an early stage,
\nwhen they are generally easier to treat.<\/p>\n

If interim data are positive, the NHS in England plans to roll out the test to a further one million
\npeople across 2024 and 2025.<\/p>\n

About the trial<\/span><\/h3>\n

The NHS-Galleri trial is a prospective, Randomised Controlled Trial (RCT). Following baseline
\nblood collection, participants were randomised (1:1) to either:<\/p>\n

I. Intervention (\u2018test\u2019) arm – blood is sent for analysis using the Galleri test.
\nII. Control arm – blood is stored and may be tested in the future.<\/p>\n

Participants remain blinded throughout the trial unless they are among the minority of
\nparticipants in the intervention arm who receive a \u2018Cancer Signal Detected\u2019 result. Participants
\nwith a \u2018Cancer Signal Detected\u2019 result are informed by a trial nurse and referred to the NHS for
\ndiagnostic investigation as an urgent suspected cancer referral<\/p>\n

All participants are advised to continue with their standard NHS screening appointments and to
\ncontact their GP if they notice any new or unusual symptoms.<\/p>\n

The NHS-Galleri trial is being run by The Cancer Research UK & King\u2019s College London Cancer
\nPrevention Trials Unit in partnership with the NHS and healthcare company, GRAIL, which
\ndeveloped the Galleri test.<\/p>\n

The trial is operating with the support of eight NHS Cancer Alliances across England: Cheshire
\nand Merseyside, East Midlands, East of England (North), Greater Manchester, Kent and
\nMedway, Northern, South East London, and West Midlands.
\nFor further information about the trial visit https:\/\/www.nhs-galleri.org<\/p>\n

About the Galleri test<\/span><\/h3>\n

The Galleri test recognises methylation patterns in cell-free DNA (cfDNA; DNA released into the
\nblood by apoptosis or necrosis of noncancerous and tumour cells). The detection of a
\nmethylation pattern associated with cancer is returned as a \u2018Cancer Signal Detected\u2019 result, at
\nwhich point a further analysis is performed to predict the \u2018Cancer Signal Origin\u2019 (CSO). Up to two
\ncancer signals may be reported, with the first signal listed having a higher likelihood of being
\ncorrect.<\/p>\n

The CSO can be used to inform the appropriate NHS referral pathway to investigate a
\npotential cancer diagnosis. A \u2018Cancer Signal Detected\u2019 result has previously been reported to
\nhave a positive predictive value (PPV) in the region of 40% (Klein et al, 2021). CSO prediction
\naccuracy for the first or second CSO in participants with a \u2018Cancer Signal Detected\u2019 result is
\nreported to be around 88% (Klein et al, 2021).<\/p>\n

References<\/span><\/h3>\n

Klein EA, Donald R, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J,
\nHunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C and Liu MC, 2021, Clinical
\nValidation of a Targeted Methylation Based Multi-Cancer Early Detection Test. American
\nAssociation for Cancer Research (AACR) Annual Meeting, 10-15 April and 17-21 May, virtual
\nconference (https:\/\/grail.com\/wp\u0002content\/uploads\/2021\/04\/CCGA3_Klein_AACR_2021_oral_FINAL.pdf)<\/p>\n ","protected":false},"excerpt":{"rendered":"

Clinicians’ briefing produced by GRAIL, Cancer Research UK and King’s College London – September 2022.
\nThis briefing is to update primary and secondary care clinicians about the NHS-Galleri trial as it
\nmoves into its second operational year.<\/p>\n","protected":false},"author":500,"featured_media":15905,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[63],"tags":[],"_links":{"self":[{"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/posts\/19930"}],"collection":[{"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/users\/500"}],"replies":[{"embeddable":true,"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/comments?post=19930"}],"version-history":[{"count":2,"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/posts\/19930\/revisions"}],"predecessor-version":[{"id":19934,"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/posts\/19930\/revisions\/19934"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/media\/15905"}],"wp:attachment":[{"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/media?parent=19930"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/categories?post=19930"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.stockportpracticehub.co.uk\/practicehub\/wp-json\/wp\/v2\/tags?post=19930"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}