������

New trial aims to improve early diagnosis of pancreatic cancer

A new blood test which aims improve the early detection of one of the most under-diagnosed and difficult to treat cancers is to be trialled by researchers at the Southampton Clinical Trials Unit.

The Avantect test, developed by biotechnology company ClearNote Health, looks for signs of pancreatic cancer in blood.

The SAFE-D study (Surveillance of pAncreatic health aFter diabEtes Diagnosis) is sponsored by University Hospital Southampton NHS Foundation Trust (UHS) and is led by Zaed Hamady, a consultant surgeon and pancreatic researcher at the ������, and will evaluate how well the test can detect pancreatic cancer at an earlier stage, when it is curable.

The trial will use blood samples from people with a recent diagnosis of type 2 diabetes, a known risk factor for developing pancreatic cancer.

A need for improved diagnosis

Pancreatic cancer is the 10 ^th most common cancer in the UK with around 10,500 people diagnosed each year*, while nearly half a million people are diagnosed every year worldwide**.

But because the symptoms of pancreatic cancer can be vague and often put down to other things, most patients are diagnosed at a late stage when the cancer has grown too large to be removed surgically. This means that survival rates are lower than for many other types of cancer.

“Improving the early diagnosis of pancreatic cancer is vital,” says Mr Hamady. “However, there is currently no targeted early detection or surveillance test for the disease meaning patients are often only picked up when they become unwell and go to the hospital as an emergency. If we can develop approaches to detect the cancer sooner, then there are more options we may consider to treat the disease, and patients will have a much better chance of long-term survival.”

Spotting the signs early

There are several known risk factors for pancreatic cancer, one of which is diabetes, a disease of the pancreatic cells that make the hormone insulin. People with newly diagnosed type 2 diabetes have a 1% risk of also being diagnosed with pancreatic cancer within three years.

The SAFE-D study will therefore focus on this patient group to trial the new DNA-based early detection blood test and see how well it is able to detect signs of the cancer in its early stages.

“We will be asking people with newly diagnosed type 2 diabetes who are attending GP surgeries or diabetic clinics, whether they would like to take part in the study,” says Angelica Cazaly, Senior Trial Manager for SAFE-D at the Southampton Clinical Trials Unit. “For the initial pilot phase of the trial, we will collect blood samples from 800 people for testing, before moving to the next, larger phase of the study. All participants will be monitored for two years.”

The results from the blood test, together with medical information collected from each patient, will help researchers see how well the Avantect test is able to accurately predict the early signs of pancreatic cancer.

Mr Hamady continues: “Although most people with diabetes will not go on to develop the disease, new onset diabetes is associated with a 6-8-fold increased risk. This patient group gives us a way to test how accurate the new diagnostic blood test is, and that could potentially help thousands of people in the future.”

Samuel Levy, chief scientific officer of ClearNote Health, said: “Early diagnosis of the deadliest cancers to enable patients to live longer, healthier lives is our mission at ClearNote Health. Our early data supports the ability of Avantect to identify pancreatic cancer in its earliest stages (I/II), and we are excited to collaborate with the University Hospital Southampton NHS Foundation Trust and Southampton Clinical Trials Unit. The SAFE-D study will give patients with new onset type 2 diabetes that may have pancreatic cancer a better chance to secure a cure.”

Dr Mikayala King, Research and Development Governance, Quality Assurance and Sponsorship Manager at University Hospital Southampton NHS Foundation Trust, said: "We are excited to be sponsoring this cutting-edge study with potential benefit to patients with this devastating disease. We are happy to be working with ClearNote and to be building on our long-established relationship with the CTU to manage and deliver the project.”

The SAFE-D study is currently in set-up and will begin recruiting participants in early 2025.

Further information may be found at: /ctu/safe-d.page

The SAFE-D study is primarily funded by ClearNote Health with additional financial support from Cancer Research UK Core funding at the Southampton Clinical Trials Unit and is sponsored by the University Hospital Southampton NHS Foundation Trust.

* Figures from Cancer Research UK -

** Figures from the National Library of Medicine -