Work Package 1 - Recruiting people newly diagnosed with diabetes
Lead: Professor Christopher Halloran
We are recruiting 2,500 individuals aged 50 years or older who have been diagnosed with Type 2 diabetes within the last 6 months. Participants are asked to provide blood samples, lifestyle and clinical information every six months for two years. We are recruiting participants from GP practices and NHS centres from across the UK. Around 1% of participants will go on to be diagnosed with pancreatic cancer within three years. The samples and data that are collected from those individuals before their cancer diagnosis could hold crucial clues that allow earlier pancreatic cancer detection in future.
Work Package 2 - Bio-banking of samples
Lead: Professor William Greenhalf
We are collecting, processing and storing blood samples in the Liverpool Good Clinical Practice laboratories. Using the standards of Good Clinical Practice will allow us to carry out robust research on the samples. It also allows us to meet the requirements of future researchers and ensure harmonisation with samples collected from similar cohorts in the United States and the European Union.
Work Package 3 - Validating biomarkers that distinguish type3c diabetes from type 2 diabetes
Lead: Professor Eithne Costello
Diabetes that occurs because of pancreatic cancer is called type 3c diabetes. Currently there are no tests that easily allow type 3c diabetes to be distinguished from the more prevalent type 2 diabetes. Researchers are working to develop blood tests that can make this distinction. The blood samples and data we are collecting as part of UK-EDI will provide a much-needed resource to evaluate whether emerging blood tests are valid. Importantly, because we are taking samples before pancreatic cancer is diagnosed, it should be possible to detect changes that occur early during the course of pancreatic cancer, allowing earlier detection of pancreatic cancer in future.
Work Package 4 - Developing a risk stratification model for pancreatic cancer in individuals with new-onset diabetes
Lead: Professor Laurence Alison
Alongside blood samples, we are asking participants to provide lifestyle and clinical data. We will be scrutinising data from all sources looking for differences between the 1% who proceed to a diagnosis of pancreatic cancer and the 99% who do not. Using direct model building, we aim to build a pancreatic cancer risk score to stratify individuals with new-onset diabetes into those at low or high risk of having pancreatic cancer. We will take into consideration end-user need and how modelling can be best utilised by practitioners.
Work Package 5 - Undertaking biomarker discovery using new-onset diabetes cohorts
Lead: Dr Lucy Oldfield
The blood samples collected as part of UK-EDI provide a unique resource. The samples are taken from participants soon after the diagnosis of diabetes but before the diagnosis of pancreatic cancer. These samples could hold valuable information on changes that occur in the months or years before pancreatic cancer is currently diagnosed. We will therefore analyse the samples using the latest available technologies, comparing them to control samples from participants newly diagnosed with diabetes who are not subsequently diagnosed with pancreatic cancer. Well characterised pre-diagnostic samples of this kind do not currently exist, and UK-EDI is generating a unique resource in the United Kingdom.
Work Package 6 - Determining the cost-effectiveness of screening individuals with new-onset diabetes for pancreatic cancer
Lead: Professor Robert van Der Meer
We will assess the cost-effectiveness of earlier diagnosis of pancreatic cancer. Models will combine clinical, epidemiological and economic data, and the key outcome measure will be a cost per quality-adjusted life-year gained or lost. We will also explore how costs change over time as a consequence of the new intervention. This will provide an important economic evidence-base for the development of policies regarding screening people with new-onset diabetes for pancreatic cancer.
Work Package 7 - Managing and engaging stakeholders
Lead: Professor Eithne Costello
We wish to raise awareness in the United Kingdom about the link between new-onset diabetes and pancreatic cancer. We will share our research results as widely as possible within the scientific and clinical communities, as well as within the healthcare and pharmaceutical sectors and the general population. Research is much needed in this area. Given that a new diagnosis of diabetes could be a warning sign of pancreatic cancer, it is important to provide GPs with the tools they need to assess whether a patient is at high or low risk of having pancreatic cancer. UK-EDI is providing the resource to develop these tools. We will also explore future clinical trials to establish early detection of pancreatic cancer in asymptomatic individuals in high-risk populations.