Does screening with the Galleri test in the NHS reduce the likelihood of a late-stage cancer diagnosis?

Not Applicable

• Conditions: Multi cancer early detection in people without symptoms; Cancer

• Registration Number: ISRCTN91431511
• Lead Sponsor: GRAIL Bio UK Ltd.

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36230741/ (added 17/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 4 December 2023
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 140000

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Incidence and stage at diagnosis for cancer types that are stageable (e.g., with available staging systems) measured using patient records.<br> Cancer is defined as any of the following cancers:<br> ? Invasive solid cancer, excluding basal cell carcinoma and squamous cell carcinoma of the skin<br> ? Haematologic malignancies, including lymphoma, lymphoid leukemia,<br> myeloma/plasma cell neoplasm, myeloid neoplasms (including myelodysplastic and myeloproliferative neoplasms with behaviour code 3 based on ICD-O-3.2).<br> 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.<br>