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What is the SAFE-D study?

Background and study aim

The aim of the SAFE-D research study is to evaluate a novel blood test, the Avantect test, to detect clues or biomarkers for the presence of pancreatic cancer in people that have been newly diagnosed with type II diabetes.ÌýÌý

According to the 2021 National Diabetes Audit, about 240,000 patients are diagnosed with diabetes every year in England. Unfortunately, it is known that this particular group of people have up to ten times higher-than-average risk of developing pancreatic cancer. Pancreatic cancer is a cancer that is currently very hard to diagnose in its early stages making it harder to treat successfully. However, if diagnosed early enough, it is possible to prolong survival by removing the cancer with surgery.

There is currently no approved screening test for pancreatic cancer. The Avantect test, developed by ClearNote Health, is a new test designed to detect minute quantities of biomarkers in the blood that will flag the possible presence of pancreatic cancer at a very early treatable stage, before symptoms become apparent. The test is non-invasive and so poses virtually no risk to patients, yet if proven to accurately detect the presence of pancreatic cancer early enough, will have life-changing benefits for thousands of people with newly diagnosed type II diabetes.

The SAFE-D research study will initially recruit 800 participants aged between 50-84 who have been newly diagnosed with type II diabetes (within 6 months) into a 6-month long Pilot study, before we will roll this into a larger study.

The SAFE-D study is currently in development and will begin recruitment in 2025. In the meantime, if you require any further information please contact the SAFE-D team on safed@soton.ac.uk .

The wealth of information provided by study participants will allow us to determine if the Avantect test can be used as a reliable test to monitor individuals with new onset diabetes in the future, as well as help us understand and treat pancreatic cancer patients better. With this in mind, we are deeply grateful to anyone interested in taking part.

Who can participate?

Adults between the age of 50 – 84 years with newly diagnosed type II diabetes mellitus (within previous six months) across the UK.

The SAFE-D study isÌýprimarily funded by ClearNote Health with additional financial support from Cancer Research UK Core funding at the Southampton Clinical Trials Unit