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Observational study to assess a multi-cancer early detection test in individuals referred with signs and symptoms of cancer

 

SYMPLIFY trial logo

 

SYMPLIFY - Observational study to assess a multi-cancer early detection test in individuals referred with signs and symptoms of cancer

Chief Investigator: Professor Mark Middleton

Sponsor: University of Oxford

BACKGROUND

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.

PRIMARY OBJECTIVE

The SYMPLIFY study is in place to evaluate the performance of one such multi-cancer early detection (MCED) test known as Galleri™.

 ABOUT SYMPLIFY

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 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

STUDY STATUS AND PROGRESS

  • Recruitment to the study commenced on 5th July 2021 and the first participant was recruited on 7th July, 2021.
  • Recruitment to the study ended on 30 November 2021 and an incredible 6238 people took part in the study.
  • SYMPLIFY recruited at sites across the UK with a total of 44 hospitals throughout England and Wales involved in the study. This includes 13 NHS Trusts in England and 18 hospitals in Wales coordinated by Velindre University NHS Trust. 

NHS Trusts in England:

-          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

-          Chelsea and Westminster Hospital NHS Foundation Trust

University Health Boards (UHB) in Wales:

-          Aneurin Bevan UHB

-          Betsi Cadwaladr UHB

-          Cardiff & Vale UHB

-          Cwm Taf Morgannwg UHB

-          Hywel Dda UHB

-          Swansea Bay UHB

  • In excess of 22,000 tubes of blood were collected as part of the study. These blood samples were sent to a laboratory in the UK and then sent to the US for analysis using the GalleriTM test.
  • The study is ongoing with participant follow-up data currently being collected. This part of the study involves the collection of health status information from various NHS records and NHS registries for up to 12 months after enrolment in the study.
  • Expected study end date:  30th June 2023

Please note that recruitment to the study has ended. The following bullet points are the entry criteria that were in place for this study:

INCLUSION CRITERIA

  • Willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Referred to a RDC or a gynae, lung, upper GI or lower GI cancer 2WW pathway.

EXCLUSION CRITERIA

A potential participant may not enter the study if ANY of the following apply:

  • has a history of invasive or haematological malignancy diagnosed within the previous 3 years
  • has undergone definitive treatment for invasive or haematological malignancy in the last 3 years (adjuvant hormone therapy is permissible in this context).
  • is taking cytotoxic or demethylating agents such as methotrexate
  • previous or current participation in another GRAIL study. “Participation” is defined as having signed consent and provided a blood sample.

 

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