A randomised 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.

GRAIL Bio UK Ltd.0 sites140,000 target enrollmentSeptember 16, 2021

Overview

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

Registry

who.int

Start Date

September 16, 2021

End Date

February 28, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

GRAIL Bio UK Ltd.

•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.

•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.