Clinical trial · Interventional
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 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
NCT05611632CI-TRIAL-00117623NHS-Galleriactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-cancer early detection test (Galleri test) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- Blood collection and multi-cancer early detection testing with return of positive test results.
- interventionNames
- Device: Multi-cancer early detection test (Galleri test)
- type
- NO_INTERVENTION
- label
- Control
- description
- Blood collection only.
Primary outcomes (1)
- measure
- incidence of stage III and IV cancers diagnosed in the intervention arm as compared with the control arm
- timeFrame
- 3-4 years after randomization
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 77 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. 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. Exclusion Criteria: 1. Previous or current participation in another GRAIL-sponsored study. 2. 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 3. 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). 4. Currently taking demethylating or cytotoxic agents for any condition. 5. 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. 6. Currently on a palliative care pathway.
References
Publications (6)
- BACKGROUNDMarlow 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
- BACKGROUNDNeal 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
- BACKGROUNDBrentnall 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
- DERIVEDMarlow 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
- DERIVEDSwanton 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
- DERIVEDSmittenaar 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.