Multi cancer early detection in people without symptoms Cancer
Conditions
Interventions
A prospective, randomised, 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.
R
Sponsors
GRAIL Bio UK Ltd.
Eligibility
Sex/Gender
All
Age
50 Years to 77 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 13/04/2026: 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. Time frame: 3-4 years after randomization _____ Previous primary outcome(s): 1. Incidence and stage at diagnosis for cancer types that are stageable (e.g., with available staging systems) measured using patient records. Cancer is defined as any of the following cancers: ? Invasive solid cancer, excluding basal cell carcinoma and squamous cell carcinoma of the skin ? Haematologic malignancies, including lymphoma, lymphoid leukemia, myeloma/plasma cell neoplasm, myeloid neoplasms (including myelodysplastic and myeloproliferative neoplasms with behaviour code 3 based on ICD-O-3.2). The following cancer types are not routinely staged and will therefore be excluded from the analysis of this primary objective: brain cancers, leukemias, cancers of unknown primary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 13/04/2026: 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. Time frame: 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. Time frame: 1 year after randomization 3. Incidence of all cancers diagnosed in the intervention arm as compared with the control arm Time frame: 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 Time frame: 2 year 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. Time frame: 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. Time frame: 3-4 years after randomization 7. Stage distribution by cancer type for the two arms. Time frame: 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. Time frame: 3-4 years after randomization 9. Incidence of stage III/ IV cancers following the third blood draw. Time fram | — |
Countries
England, United Kingdom
Contacts
Public ContactCherry Paice
Outcome results
None listed