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 cfDNA) can be detected in the blood as the tumour develops. Researchers can take advantage of this, by developing technologies that detect cfDNA, 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.
Partnering with GRAIL, SYMPLIFY will evaluate the use of a GRAILs new multi-cancer early detection (MCED), known as Galleri, for patients in the NHS with non-specific symptoms that may be a result of cancer.
The aim of the SYMPLIFY study is to demonstrate how the test could be used to increase cancer detection rates and simplify diagnostic pathways. Beginning in Summer 2021, SYMPLIFY seeks to recruit around 6,000 symptomatic patients from sites across England and Wales, who have been referred by their GP for testing of their blood samples with Galleri. Results of the Galleri tests will then be used for test validation purposes.
Galleri is a blood test 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.
Dr Brian Nicholson, practicing GP and Lead Investigator of SYMPLIFY based at the Nuffield Department of Primary Care Health Sciences, University of Oxford, said:
“We’re very excited to understand the performance of this technology in patients with symptoms of possible cancer referred by their GP for urgent investigation: through this study we hope to develop an understanding of how these technologies might complement existing cancer pathways in the NHS to improve outcomes for patients.”
Professor Mark Middleton, Chief Investigator from the University of Oxford said:
‘The process of diagnosing cancer can often be lengthy and involve expensive imaging or invasive biopsies specific to only one cancer. Often this happens after a patient presents with symptoms and a cancer is more progressed. If we can intervene at an earlier stage and detect a cancer using minimally invasive tests, such as Galleri, we have the potential to accelerate cancer diagnoses and reduce the number of diagnostic procedures.
‘Ultimately these tests could transform cancer patient care within the next five years by improving the chance of successful treatment and survival.’
SYMPLIFY will assess how Galleri can be used to benefit patients with non-specific symptoms that may be a result of cancer. The SYMPLIFY study is one of the UK-based clinical trials that GRAIL is supporting, along with the recently announced 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.