A trial looking at a new blood test to help diagnose cancer earlier (SYMPLIFY)

Cancer type:

Anal cancer

Bile duct cancer

Biliary tree cancers

Bowel (colorectal) cancer

Cervical cancer

Gallbladder cancer

Liver cancer

Lung cancer

Oesophageal cancer

Ovarian cancer

Pancreatic cancer

Small bowel cancer

Stomach cancer

Vaginal cancer

Vulval cancer

Womb (uterine or endometrial) cancer

Status:

Results

Phase:

Other

This study looked at a blood test called a multi cancer early detection (MCED) test. It is also called the Galleri test.

It was for people who were having tests for symptoms that might have been cancer.

The study was open for people to join between July and November 2021. The team published the results in 2023.

More about this trial

An early diagnosis of cancer is easier to treat. The NHS has developed rapid referrals for symptoms that might be caused by cancer. Your GP arranges for you to have tests or to see a hospital doctor (specialist) urgently. You might have some tests to find out what is wrong and whether or not it could be cancer. This means testing a lot of people who don’t turn out to have cancer.

Researchers developed the Galleri test to detect cancer early. The test was developed for use in people without symptoms. But the study team wanted to find out how well it worked in people with symptoms that might be due to cancer. For this they tested blood samples from people referred to the hospital because they might have had cancer.

Cancer can release small bits of DNA Open a glossary item into the blood. This is called circulating tumour DNA or ctDNA . The Galleri test looks at ctDNA in the blood. There were two main studies running in the UK to help understand how well this blood test works.

In this study everyone had the usual tests to check for cancer as well as the Galleri test.

The main aim of this study was to check if this test can detect different types of cancer.

Summary of results

6,238 people took part. Of these 5,461 had the Galleri test and a result from the standard tests for cancer. The team followed these people up until they had a confirmed diagnosis or for up to 9 months.

Of the 5,461 people:

368 (7%) had cancer
5,093 (93%) didn’t have cancer

The team looked at the number of people with a positive test who were also diagnosed with cancer. In this study, 323 had a positive test and 244 of them actually had cancer. So 75 out of every 100 (75%) of the positive tests were true positives.

The also looked at the proportion of people with a negative test who don’t have cancer. In this study, 5,093 people didn’t have cancer of whom 5,014 (98%) had a negative test. 79 people had a negative test but were diagnosed with cancer.

The team also looked at whether the test could tell what type of cancer people had. They found that for just over 85 people out of every 100 (85%) who had a positive test and were diagnosed with cancer the test accurately identified where the cancer started.

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

Conclusion
The team concluded that this first study looking at this test in people with symptoms showed that it could be useful. The test could help doctors make decisions about referring people with symptoms that might be cancer for tests and how urgent it is.

It might also help doctors decide what cancer test is best for a patient. The test is not yet good enough to say that some people with symptoms who would normally have tests for cancer don’t need them.

More detailed information
There is more information about this research in the reference below.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study
B. D Nicholson and others
Lancet Oncology, 2023. Volume 24, pages 733 to 743.

Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.