The SYMPLIFY study will evaluate the revolutionary multi-cancer blood test Galleri, for future implementation in the NHS.
Cancer is easier to treat if it is diagnosed early. There is a need to improve screening pathways and develop new diagnostic technologies that reduce the impact on NHS resources whilst specifically detecting those with cancer at an earlier stage.
DNA from cancer cells (called ctDNA) can be detected in the blood at early tumour stages. Researchers can take advantage of this, by developing technologies that detect ctDNA, and thus find cancers earlier than existing pathways.
The SYMPLIFY study is in place to assess the performance of one such multi-cancer early detection (MCED) test known as Galleri™.
Opening to recruitment in July 2021, SYMPLIFY is assessing the performance of the MCED test Galleri in people sent to one of five rapid referral pathways by their GP, because they are displaying symptoms that might be due to cancer. People taking part in the study have their diagnostic test(s) in the normal way, but also give a blood sample and permission for the SYMPLIFY team to check their health records later to see if they were diagnosed with cancer and what appointments and other tests they had.
Galleri is a blood test developed by GRAIL LLC. that can detect over 50 types of cancers — over 47 of which lack recommended screening in the UK today — with a low false positive rate of less than 1 percent, all through a single blood draw. Using revolutionary next-generation sequencing technology, Galleri has the potential to complement existing screening programmes and current tests to enhance early stage diagnosis, when cancers can be treated more successfully.
At the end of the study, having tested the blood with the MCED test, the team will understand more about how well it works in this group of people. This will help them to design another trial where they can check how to implement the test to decide who needs rapid referral to look for a possible cancer and what tests to use following a positive MCED result.
The SYMPLIFY study is one of the UK-based clinical trials that GRAIL is supporting, along with the NHS-Galleri trial, from which the collective results may see the MCED technology included in routine visits with healthcare providers, such as to a GPs and other non-hospital settings.
The SYMPLIFY Study is a collaboration between the University of Oxford’s Department of Oncology, the Cancer Research Group at the Nuffield Department of Primary Care Health Sciences, the Oncology Clinical Trials Office, and the Primary Care Clinical Trials Unit.
SYMPLIFY recruited at sites across the UK, including 13 NHS Trusts in England and 19 district hospitals in Wales coordinated by Velindre University NHS Trust. England recruiting sites:
- Buckinghamshire Healthcare NHS Trust
- Hull University Teaching Hospitals NHS Trust
- Mid and South Essex NHS Foundation Trust
- North Middlesex University Hospital NHS Trust
- Oxford University Hospitals NHS Foundation Trust
- Royal Berkshire NHS Foundation Trust
- Royal Cornwall Hospital NHS Trust
- Royal Free London NHS Foundation Trust
- Torbay & South Devon Foundation Trust
- University College London Hospitals NHS Foundation Trust
- University Hospital Southampton NHS Foundation Trust
- York & Scarborough Teaching Hospitals NHS Foundation Trust