Trial of new blood test to improve the early detection of pancreatic cancer

A fundraiser who lost his wife to pancreatic cancer just four weeks after she was diagnosed says he’s hopeful a new blood test that may detect the disease at an earlier stage could prevent similar heartache for other families.

When Sean Cleghorn’s wife, Allison, discovered she had the disease during Christmas 2020, her cancer was so advanced, she was unable to receive chemotherapy and she died in January 2021, aged 54.

Now a new trial has been launched at the Cancer Research UK Southampton Clinical Trials Unit to establish how well a new blood test can spot the signals of pancreatic cancer at an early stage.

The Avantect test, developed by biotechnology company ClearNote Health, will use blood samples from people with a recent diagnosis of type 2 diabetes – a known risk factor and potential sign or symptom of pancreatic cancer.

Sean, a father of three from Kingsclere in Hampshire, said: “The only symptom Allison displayed was some slight indigestion and then she was diagnosed with type 2 diabetes in the autumn of 2020.

“Allison had always eaten healthily, was active and avoided processed food, so this diagnosis was puzzling for us. When we learned that new onset type 2 diabetes was a potential risk factor for pancreatic cancer, we asked for further testing and a scan on December 23rd that year confirmed she had terminal cancer.

“We hoped she could have chemotherapy to prolong her life, but she became too weak and died four weeks later.”

Sean, who has helped to raise £80,000 for Cancer Research UK with the Kingsclere Cancer Research Fundraiser group to help with this kind of progress, continues: “Perhaps if she had been diagnosed sooner with a test like the one that’s currently being trialled, we may have had time to make more memories with our three children.”

Pancreatic cancer is the 10th most common cancer in the UK but the 5th most common cause of cancer death. Around 10,500 people in the UK are diagnosed with the disease 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 such as a diabetes diagnosis, most patients are diagnosed at a late stage when the cancer has grown too large to be removed surgically. This means that survival is lower than for many other types of cancer. Around 1 in 10 (8.3%) people diagnosed with pancreatic cancer in England survive their disease for 5 years or more.***

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 University of Southampton, and will evaluate how well the test can detect pancreatic cancer at an earlier stage, when it is curable.

“Allison and Sean’s story is, unfortunately, not that unusual and improving the early diagnosis of pancreatic cancer is therefore vital,” said Mr Hamady. “However, there is currently no targeted early detection or surveillance test for the disease meaning patients are often diagnosed late when they become really unwell. 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.”

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 over 50 with newly diagnosed type 2 diabetes have a 1 in 100 risk of also being diagnosed with pancreatic cancer within three years of diabetes diagnosis.

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

Angelica Cazaly, Senior Trial Manager for SAFE-D at the Southampton Clinical Trials Unit, said: “We are 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. Initially, we will collect blood samples from 800 people for testing. The results from the test, together with medical information collected from each patient, will help provide researchers with important information on how best to proceed with the rest of the study that will evaluate how accurate the test is at predicting pancreatic cancer.”

If the pilot phase is successful, the team will then move on to a much larger phase of the study involving many more patients.

Jen Lewis was just 14 when her dad, Malcolm, died from the disease at the age of 61, leaving behind his wife and seven children. By the time he was diagnosed, his cancer was already advanced and despite two major surgeries, he passed away shortly after beginning chemotherapy treatment.

Jen, 39, who's from Moordown in Dorset said: “My dad had type 2 diabetes and research like this is vitally important. In my Dad’s case, the cancer had been silently growing and it had spread so quickly by the time he found out had he it. Any test that could potentially help people diagnose it an earlier stage is a plus for me.

“Because my brother and I were quite young, we weren’t aware my dad had cancer until he had his first operation. I can still vividly remember the last few days of his life – it was a nasty end and I couldn’t talk about it for months.

“Knowing that research like this is happening has given me such a boost. I hope it can help other families.”

An important element of SAFE-D is that the trial is being carried out at community-based research hubs, making participation as easy as possible. The trial is now open at several community locations across the UK**** and the first patients have been recruited to the study.

Dr Victoria Goss, Head of Early Diagnosis and Translational Research at the Southampton Clinical Trials Unit, said: “We know that some people struggle to access healthcare services and research trials due to where they live or their circumstances. Being able to take this study into the community through local research hubs and community hospitals is essential to ensuring we are making our trials equitable and hopefully helping to reduce health inequalities by making early cancer diagnosis more accessible to all.”

Samuel Levy, chief scientific officer of ClearNote Health, said: “ClearNote Health is focused on improving early detection of the deadliest cancers to enable patients to live longer, healthier lives. Our early data demonstrate that our Avantect test can identify pancreatic cancer in stages I and II. We are excited to collaborate with the Cancer Research UK Southampton Clinical Trials Unit and the University Hospital Southampton NHS Foundation Trust on this transformative study that could redefine how pancreatic cancer is detected and managed for patients at high risk.”

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.”

Further information may be found at: https://safe-d.uk/

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. It is supported by Wessex Health Partners, a regional partnership bringing together Integrated Care Boards, top universities and leading NHS organisations, and offers excellence in research, innovation and health and care education.