Active — Not RecruitingNot Applicable

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

United Kingdom142,318 participantsStarted 2021-08-31

Plain-language 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.

Who can participate

Age range50 Years – 77 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 3-4 years after randomization

Trial details

NCT IDNCT05611632

SponsorGRAIL, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

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