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CancerNHS-GalleriNCT05611632

Does Screening With the Galleri Test in the NHS Reduce the Likelihood of a Late-stage Cancer Diagnosis in an Asymptomatic Population? A Randomised Clinical Trial

A study testing Multi-cancer early detection test (Galleri test) in people with Cancer, run by GRAIL, Inc. at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The Galleri test is a new test that looks for potential signs of cancer in a blood sample. The test can find many different types of cancer but cannot find all cancers. The trial aims to see if using the Galleri test alongside standard cancer testing in the NHS can help to find cancers at an early stage when they are… Read more about this study

Who is it for?
Ages 50 to 77 yearsHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Multi-cancer early detection test (Galleri test)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142,318 participants
Where
1 siteUnited Kingdom
Study dates
31 Aug 2021to Jan 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 77 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants must be at 50-77 years of age, inclusive, at the time of data extraction from NHS datasets or GP records used to identify potential participants; and
  • Capable of giving signed and legally effective informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. Consent provided by a legally authorised representative is not permitted in this protocol.

Who cannot join

  • Previous or current participation in another GRAIL-sponsored study.
  • Personal history of invasive cancer or haematologic malignancy, diagnosed within the three years prior to expected enrolment date. Note: Individuals with a diagnosis of non-melanoma skin cancer and prostate cancer patients whose only treatment is active surveillance are NOT excluded
  • Definitive treatment for invasive cancer or haematologic malignancy within the 3 years prior to expected enrolment date, including adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer).
  • Currently taking demethylating or cytotoxic agents for any condition.
  • Undergoing current investigation for suspected cancer, defined as having been referred to a two week wait clinic or undergoing investigations at an RDC or other clinic with a stated suspicion of cancer.
  • Currently on a palliative care pathway.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • EMS Healthcare Ltd

    Macclesfield

Other trials in United Kingdom

About this study

Official title: A Randomized, Controlled Trial to Assess the Clinical Utility of a Multi-cancer Early Detection (MCED) Test for Population Screening in the United Kingdom (UK) When Added to Standard of Care

The Galleri test is a new test that looks for potential signs of cancer in a blood sample. The test can find many different types of cancer but cannot find all cancers. The trial aims to see if using the Galleri test alongside standard cancer testing in the NHS can help to find cancers at an early stage when they are easier to treat.

The trial has enrolled approximately 140,000 participants who will be actively followed for approximately three years from the date of enrollment.

Read the detailed description

This is a prospective, randomized, controlled trial to assess the performance and clinical utility of a multi-cancer early detection test for population screening in the UK when added to standard of care. Participants and the study teams remain blinded throughout the study with the exception of the study nurses returning the results and a small number of staff to enable them to perform administrative duties. Blinding is maintained for participants with the exception of those participants who test positive. Those who test positive will be informed by designated trial staff and will be referred for standard of care investigations and treatment. Trial sponsor employees, the CIs and site staff (unless identified differently in the blinding plan for study conduct needs) will remain blinded throughout the study.

Randomization will be to either the intervention arm, with blood collection and evaluation of the test with consequent investigation and treatment of a positive test through referral to the NHS urgent two week wait pathway, or to the control arm, where blood samples are collected at designated intervals and will be stored for potential future evaluation, but participants do not receive test results and otherwise continue to receive routine NHS care.

Unless diagnosed with cancer, participants in both arms will be asked to return for annual visits at approximately 12 and 24 months. All participants whether test positive, test negative or not tested will be followed for cancer and associated outcomes via NHS dataset linkages.

Conditions
Cancer
Being tested
Multi-cancer early detection test (Galleri test)
Keywords
multi-cancer early detection, cancer screening, MCED, circulating cell-free tumor DNA
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-cancer early detection test (Galleri test)Device

    Also called Galleri test

    Blood collection and multi cancer early detection testing with return of positive test results.

Study groups in NCT05611632
Study groupRoleWhat they receive
InterventionalExperimentalBlood collection and multi-cancer early detection testing with return of positive test results.
Receives: Device: Multi-cancer early detection test (Galleri test)
ControlNo interventionBlood collection only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of stage III and IV cancers diagnosed in the intervention arm as compared with the control arm

    using a fixed-sequence statistical strategy as below:

    • first, evaluate for a statistically significant difference in a prespecified group of primary cancer types: lung, head \& neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, oesophagus, anus, lymphoma, ovary, and bladder.
    • if a statistically significant reduction in absolute numbers is found, continue by evaluating for a difference in all cancer types excluding prostate cancer.
    • If the above evaluations are both significant, evaluate for a difference in all cancer types.

    Measured: 3-4 years after randomization

Secondary outcomes (17)
  1. incidence of advanced cancers (stage III and IV cancers or one that results in a cancer-specific death) diagnosed in the intervention arm as compared with the control arm.

    Measured: 3-4 years after randomization

  2. incidence of stage IV cancers diagnosed in the intervention arm as compared with the control arm

    sequentially:

    • for a prespecified group of 12 cancer types: lung, head \& neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, esophagus, anus, lymphoma, ovary, and bladder.
    • for all cancer types excluding prostate cancer.
    • for all cancer types.

    Measured: 1 year after randomization

  3. incidence of all cancers diagnosed in the intervention arm as compared with the control arm

    Measured: 1 year after randomization

  4. incidence of stage IV cancers following the second blood draw and 12 months of follow-up, with prevalent cases excluded

    Measured: 2 years after randomization

  5. incidence of stage IV cancers diagnosed in the intervention arm as compared with the control arm.

    sequentially:

    • for a prespecified group of 12 cancer types: lung, head \& neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, esophagus, anus, lymphoma, ovary, and bladder.
    • for all cancer types excluding prostate cancer.
    • for all cancer types.

    Measured: 3-4 years after randomization

  6. modelled cancer mortality at 7 years post-randomization based on cancers diagnosed within 3-4 years after randomization in the intervention arm as compared with the control arm.

    Measured: 3-4 years after randomization

  7. stage distribution by cancer type for the two arms.

    Measured: 3-4 years after randomization

  8. incidence of stage III and IV cancers excluding breast, cervical, and colorectal diagnosed in the intervention arm as compared with the control arm.

    Measured: 3-4 years after randomization

  9. incidence of stage III/ IV cancers following the third blood draw.

    Measured: 3-4 years after randomization

  10. overdiagnosis by comparing the cumulative number of cancers diagnosed within 3-4 years of randomisation in individuals with a positive baseline test (evaluated retrospectively in the control arm) between arms.

    Measured: 3-4 years after randomization

  11. cancer-specific mortality in the intervention arm as compared with the control arm.

    specifically:

    • nested cancer-specific mortality up to 5 years after randomization.
    • cancer-specific mortality (up to 5 years and) up to 8 years after randomization.

    Measured: up to 8 years after randomization

  12. proportion of stage I and II cancers in the intervention arm as compared with the control arm in the third screening round.

    Measured: 3-4 years after randomization

  13. test performance (sensitivity, specificity, positive predictive value, negative predictive value) and cancer signal origin accuracy) in the intervention arm.

    Measured: Up to 3 years after randomization

  14. participant-reported psychological impact including anxiety, at various timepoints in all test positive cases.

    Measured: Up to 1 year after randomization

  15. number and type of invasive procedures performed, and complications and deaths associated with follow-up diagnostic procedures in all test positive cases.

    Measured: Up to 3 years after randomization

  16. radiation exposure by participants associated with follow-up diagnostic procedures following a positive MCED test result.

    Measured: Up to 3 years after randomization

  17. use of the MCED test across three annual timepoints on healthcare resource utilization for cancer diagnosis and treatment.

    Measured: Up to 3 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2022
  2. Study start31 Aug 2021
  3. Primary completion12 Jun 2026
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomised to either the intervention arm, with blood collection and evaluation of the test with consequent investigation and treatment of a positive test through referral to the NHS urgent two week wait pathway, or to the control arm, where blood samples are collected at designated intervals and will be stored for potential future evaluation, but participants do not receive test results and otherwise continue to receive routine NHS care.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
142,318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05611632
Sponsor's protocol ID
GRAIL-009
Other IDs
ISRCTN91431511
Acronym
NHS-Galleri
Status last verified
Jul 2026
First submitted
28 Oct 2022
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Marlow LAV, Schmeising-Barnes N, Warwick J, Waller J. Psychological Impact of the Galleri test (sIG(n)al): protocol for a longitudinal evaluation of the psychological impact of receiving a cancer signal in the NHS-Galleri trial. BMJ Open. 2023 Jul 21;13(7):e072657. doi: 10.1136/bmjopen-2023-072657.

    PubMed 37479515
  • Neal RD, Johnson P, Clarke CA, Hamilton SA, Zhang N, Kumar H, Swanton C, Sasieni P. 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 (Basel). 2022 Oct 1;14(19):4818. doi: 10.3390/cancers14194818.

    PubMed 36230741
  • Brentnall AR, Mathews C, Beare S, Ching J, Sleeth M, Sasieni P. Dynamic data-enabled stratified sampling for trial invitations with application in NHS-Galleri. Clin Trials. 2023 Aug;20(4):425-433. doi: 10.1177/17407745231167369. Epub 2023 Apr 24.

    PubMed 37095697
  • Sasieni P, Johnson P, Round T, Warwick J, Jones H, Dolly S, Lee L, Lee Y, Kumar H, Liang W, Smittenaar R, Neal RD, Swanton C. Effect of Screening with Multicancer Early-Detection Test on Late-Stage Cancer Diagnosis. N Engl J Med. 2026 Sep 22. doi: 10.1056/NEJMoa2505723. Online ahead of print.

    PubMed 42776074
  • Neal RD, Dolly S, Johnson P, Jones H, Kumar SH, Lee LYW, Lee Y, Liang W, Round T, Smittenaar R, Warwick J, Sasieni P, Swanton C. Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial. Nat Med. 2026 Sep 22. doi: 10.1038/s41591-026-04652-8. Online ahead of print.

    PubMed 42773209
  • Marlow LAV, Schmeising-Barnes N, Waller J. Experience of NHS diagnostic investigation following a multi-cancer early detection (MCED) screening test: qualitative interviews with NHS-Galleri trial participants who had a cancer signal detected. EClinicalMedicine. 2026 Jan 8;91:103733. doi: 10.1016/j.eclinm.2025.103733. eCollection 2026 Jan.

    PubMed 41567711
  • Swanton C, Bachtiar V, Mathews C, Brentnall AR, Lowenhoff I, Waller J, Bomb M, McPhail S, Pinches H, Smittenaar R, Hiom S, Neal RD, Sasieni P. NHS-Galleri trial: Enriched enrolment approaches and sociodemographic characteristics of enrolled participants. Clin Trials. 2025 Apr;22(2):227-238. doi: 10.1177/17407745241302477. Epub 2025 Jan 25.

    PubMed 39862108
  • Smittenaar R, Quaife SL, von Wagner C, Higgins T, Hubbell E, Lee L. Impact of screening participation on modelled mortality benefits of a multi-cancer early detection test by socioeconomic group in England. J Epidemiol Community Health. 2024 May 9;78(6):345-353. doi: 10.1136/jech-2023-220834.

    PubMed 38429085

Questions about this trial

What is this clinical trial studying?

A study testing Multi-cancer early detection test (Galleri test) in people with Cancer, run by GRAIL, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of stage III and IV cancers diagnosed in the intervention arm as compared with the control arm (time frame: 3-4 years after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05611632, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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