In this interview, Dr. Victoria Goss, PhD, Associate Professor of Early Diagnosis and Translational Research, and Head of Early Diagnosis and Translational Group at the Southampton Clinical Trials Unit, discusses the SAFE-D study, the world’s largest study for early detection of pancreatic cancer in patients newly diagnosed with type 2 diabetes.
Learn why the study is important, what makes it unique and what impact the results could have on patient care or treatment decisions in the future.
• Why is the SAFE-D study needed now, and what gap in current care does it aim to address?
There is an urgent need for better and earlier detection of pancreatic cancer. Pancreatic cancer is the 10th most commonly diagnosed cancer in the UK, butdiagnosing the disease in its earliest stages can be difficult. Symptoms can be vague or mirror other conditions and therefore referral for further investigations, such as imaging, may not be requested until the cancer is at an advanced stage. In fact, around 80% of cases are diagnosed at a late stage when there are no longer effective treatment options available. Because of this, outcomes for many patients are poor and the 5 year survival rate following diagnosis is less than 10%.
Data published in 2005 showed that there is an association between newly diagnosed type 2 diabetes and an increased risk of being diagnosed with pancreatic cancer. It’s thought this could be due to the same insulin-producing cells of the pancreas being damaged by early-stage cancer, leading to a diabetes diagnosis. This provided us with an opportunity to look for an effective surveillance tool, such as a liquid biopsy-based biomarker, and trial it in this cohort of patients to see if it could increase the proportion of people diagnosed with pancreatic cancer at an earlier stage. For the SAFE-D study, we are therefore working with ClearNote Health to evaluate their Avantect Pancreatic Cancer test in this setting. A key consideration for such a study is being able to administer the test in the community. This is to ensure that all patients have easy access to this clinical trial and reduce the risk that those in disadvantaged parts of society, who we know have lower uptake rates of such tests, are not prevented from accessing early cancer detection. The Avantect Pancreatic Cancer test requires a simple blood sample, meaning it can be carried out in community settings. This has been exemplified by the team we are working with at Sherwood Forest Hospital in Nottinghamshire who have utilised their mobile research bus to allow recruitment and study visits in the heart of the community such as supermarket carparks, truly bringing research to the population.
The SAFE-D study was launched in May 2025 and includes high-risk type 2 diabetes patients within 6 months of diagnosis, who will be taking three blood tests, six months apart as part of the study. Patients are randomised to either the control arm where they will follow standard of care approach for early pancreatic cancer detection, or an intervention arm where blood samples will be analysed within twoweeks by Avantect. Importantly, if an Avantect ‘detected’ result is found the patient will be invited for further imaging based investigation.
• From your perspective, what impact could the results have on patient care or treatment decisions in the future?
If the SAFE-D clinical study demonstrates that the Avantect Pancreatic Cancer test can increase the rate of early stage pancreatic cancer diagnoses, it is hoped that this simple blood test could be used as a standard of care early detection tool by the NHS and other health providers in the future. Before that could happen though, a health economic analysis would be needed to provide evidence that the test should be available as standard to patients who have been newly diagnosed with Type 2 Diabetes.
But our hope is that the test would provide a mechanism to identify more people with pancreatic cancer at the earliest stages of their disease.
• What makes this study unique compared to previous research in this area?
This will be the largest study performed to investigate an early detection test for pancreatic cancer and highlights the commitment of the clinical trial research team and ClearNote Health to driving research in this area forward for the benefit of patients. Data from the study will provide evidence for the performance of the Avantect Pancreatic Cancer test in this patient population and will also highlight the effectiveness of different recruitment mechanisms that we are employing to reach those in the community and invite them to take part in research. So, there are multiple exciting elements to the data that will be produced!
• What would you say to patients or clinicians who are considering taking part in the study?
As researchers, we carry out clinical studies because we want to improve people’s health, healthcare services and treatment. However, studies like SAFE-D could not happen without the patients who volunteer to take part in research providing an important impetus to improve healthcare. We have therefore been delighted that patients have responded, with some sharing moving and personal stories about why taking part in this study is so important to them and their families. Some participants have travelled from neighbouring counties to be involved while we open up across the UK, which really demonstrates the demand for both research into this area and the development of novel diagnostics that could be employed to identify those at risk of more serious underlying conditions.
We also really welcome involvement from GPs who are interested in identifying and inviting participants to take part in this research and from secondary care clinicians who would like to act as study champions for patients who are referred for an MRI scan to confirm whether or not they have pancreatic cancer.
• Looking ahead, how could participation in SAFE-D help shape the future of diagnosis or treatment for this condition?
By participating in the SAFE-D study, patients are helping to advance our knowledge in this much needed area and generate evidence for the effectiveness of a potential novel diagnostic for early pancreatic cancer detection. This means that in the future more patients will be diagnosed when there are treatment options available – and ultimately more patients will then survive this devastating disease.
Learn more about enrolment options for the study on the SAFE-D website.
Learn More About Avantect:
In the pursuit of improving pancreatic cancer testing, advancements in epigenomic and genomic science have led to the development of the Avantect Pancreatic Cancer Test. By targeting epigenomic changes and incorporating a genome-wide sequencing-based approach, the Avantect test may offer earlier detection of pancreatic cancer. Validated in high-risk patient populations, it shows promising sensitivity and specificity. These advancements emphasize the importance of exploring innovative approaches to enhance pancreatic cancer diagnostics.
Remember, if you have concerns about pancreatic cancer or any other health condition, consult with your healthcare provider for proper evaluation, diagnosis, and treatment options.
Learn more about the Avantect Test, a blood test that detects epigenomic and genomic profiles of cell-free DNA (cfDNA) associated with pancreatic cancer.
