SYMPLIFY

• Research type

  Research Study

• Full title

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

• IRAS ID

  299310

• Contact name

  Mark R. Middleton

• Contact email

  mark.middleton@oncology.ox.ac.uk

• Sponsor organisation

  University of Oxford

• ISRCTN Number

  ISRCTN10226380

• Duration of Study in the UK

  2 years, 0 months, 30 days

• Research summary

  Summary of Research

  Cancer is easier to treat if it is diagnosed early. The NHS has developed rapid referral pathways to allow cancers to be diagnosed earlier, but this requires us to run tests on a lot more people than turn out to have cancers. This creates worry for some people and may not be the most efficient use of NHS resources. A significant proportion of cancers are still diagnosed via other routes, often when it is too late to cure them. We know that the DNA from cancers can be detected in the blood early on and want to use this to detect cancers earlier than we do now. In this study we want to check the performance of one test, called a multi-cancer early detection (MCED) test. We will do this in people sent to one of 5 rapid referral pathways by their GP because they have symptoms that might be due to cancer. People taking part in the study will have their diagnostic test(s) in the normal way, but will also give a blood sample and permission for us to check their health records later to see if they were diagnosed with cancer and what appointments and other tests they had. At the end of the study, having tested the blood with the MCED test, we will understand more about how well it works in this group of people, and expect that this will help us to design another trial where we check how to use the test to decide who needs rapid referral to look for a possible cancer and what tests to use following a positive MCED result.

  Summary of Results

  A total of 6,238 people joined SYMPLIFY and we were able to compare the results of standard NHS cancer tests and the Galleri test for 5,461 people.

  2023 results
  We first looked at the results in 2023. The results of the standard NHS tests within 9 months of joining the study showed that:
  368 people (7%) had cancer
  5,093 people (93%) didn’t have cancer

  The team then looked at the number of people who had a positive Galleri test and were also diagnosed with cancer through standard NHS tests.

  We found that 323 people had a positive Galleri test and:
  244 of them (76%) had cancer - a true positive result
  79 of them (24%) did not have cancer - a false positive result

  We also looked at the number of people with a negative Galleri test who didn’t have cancer. Of the 5,093 people who didn’t have cancer, 5,014 people (98%) had a negative Galleri test.

  The team went on to look at whether the Galleri test could tell what type of cancer people had. They found that the test accurately identified where the cancer started in more than 8 out of 10 people (85%) with a true positive result.

  We also looked at how sensitive the test was depending on the of the cancer. We found it was more sensitive for more advanced cancers than it was for earlier stage cancers. It was also more accurate for people who had symptoms associated with cancers of the food pipe (oesophagus) or stomach.

  2025 results
  In 2025 the team looked at the results again. They focussed on the 79 people who had a positive Galleri test but had not been diagnosed with cancer when they had standard NHS tests within 9 months of joining the study.

  They found that 28 of these 79 people (35%) were diagnosed with cancer within 2 years of their positive Galleri test result. For some people, their cancer may have been too small to be seen on a scan when they had the positive Galleri test. And some people may have needed different tests to diagnose their cancer.

  Conclusion
  The team concluded that the Galleri test could be useful for helping to diagnose cancer in people with symptoms. And that the test could help doctors decide when to refer people with symptoms that might be cancer.

  The team also suggest that people should have further follow up appointments and tests to check for cancer if they:
  • had a positive Galleri test
  • have continued to experience symptoms that may be caused by cancer
  • have not yet been diagnosed with cancer

  This summary was co-produced with the help of Cancer Research UK and a version can be found on their website: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.cancerresearchuk.org%252Fabout-cancer%252Ffind-a-clinical-trial%252Fa-trial-looking-at-a-new-blood-test-to-help-diagnose-cancer-earlier-symplify%2FNBTI%2FEnHDAQ%2FAQ%2F5c1ed056-066f-4f05-b3ef-67b6714126a8%2F2%2FmplyQKLafw&data=05%7C02%7Clondoncentral.rec%40hra.nhs.uk%7C7f71404facc6404e12e308de6d698268%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639068497088119357%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=nC5YnrlPILKRMftu9d%2FR2JzRteDkqU%2F0KAuT1SYL%2Btk%3D&reserved=0

• REC name

  London - Central Research Ethics Committee

• REC reference

  21/LO/0456

• Date of REC Opinion

  22 Jun 2021

• REC opinion

  Further Information Favourable Opinion