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

NCT05611632 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: GRAIL-009ISRCTN91431511
• Study Type: interventional
• Target: 142,318
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cancer

Keywords

multi-cancer early detection; cancer screening; MCED; circulating cell-free tumor DNA

Outcome Measures

Primary Outcomes (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.

  3-4 years after randomization

Secondary Outcomes (17)

• 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.

  3-4 years after randomization

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

  1 year after randomization

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

  1 year after randomization

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

  2 years after randomization

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

  3-4 years after randomization

Study Arms (2)

Interventional

EXPERIMENTAL

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

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

Control

NO INTERVENTION

Blood collection only.

Interventions

Multi-cancer early detection test (Galleri test) DEVICE

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

Also known as: Galleri test

Interventional

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GRAIL, Inc.: lead
• The Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London (CPTU): collaborator

Study Sites (1)

EMS Healthcare Ltd

Macclesfield, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 37479515 BACKGROUND

• 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.

  PMID: 36230741 BACKGROUND

• 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.

  PMID: 37095697 BACKGROUND

• 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.

  PMID: 41567711 DERIVED

• 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.

  PMID: 39862108 DERIVED

• 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.

  PMID: 38429085 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Harpal Kumar

  GRAIL, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 10, 2022
• Study Start: August 31, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)