Determining the feasibility of calculating pancreatic cancer risk scores for people with new-onset diabetes in primary care (DEFEND PRIME): study protocol
Authors: Claridge Hugh , Price Claire A. , Ali Rofique , Cooke Elizabeth A. , de Lusignan Simon , Harvey-Sullivan Adam , Hodges Catherine , Khalaf Natalia , O’Callaghan Dean , Stunt Ali , Thomas Spencer A. , Thomson Joanna , Lemanska Agnieszka 
Published: September 2023

Introduction

Worldwide, pancreatic cancer has a poor prognosis. Early diagnosis may improve survival by enabling curative treatment. Statistical and machine learning diagnostic prediction models using risk factors such as patient demographics and blood tests are being developed for clinical use to improve early diagnosis. One example is the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) model, which employs patients’ age, blood glucose and weight changes to provide pancreatic cancer risk scores. These values are routinely collected in primary care in the United Kingdom (UK). Primary care’s central role in cancer diagnosis makes it an ideal setting to implement ENDPAC but it has yet to be used in clinical settings. This study aims to determine the feasibility of applying ENDPAC to data held by UK primary care practices.

Methods and analysis

This will be a multi-centre observational study with a cohort design, determining the feasibility of applying ENDPAC in UK primary care. We will develop software to search, extract and process anonymised data from 20 primary care providers’ electronic patient record management systems on participants aged 50+ years, with a glycated haemoglobin (HbA1c) test result of ≥ 48 mmol/mol (6.5 %) and no previous abnormal HbA1c results. Software to calculate ENDPAC scores will be developed, and descriptive statistics used to summarise the cohort’s demographics and assess data quality. Findings will inform the development of a future UK clinical trial to test ENDPAC’s effectiveness for the early detection of pancreatic cancer.

Ethics and dissemination

This project has been reviewed by the University of Surrey University Ethics Committee and received a favourable ethical opinion (FHMS 22-23 151 EGA). Study findings will be presented at scientific meetings and published in international peer-reviewed journals. Participating primary care practices, clinical leads and policy makers will be provided with summaries of the findings.

Strengths and limitations of this study’s methods

Early computerisation of UK primary care, incorporating linkage to pathology systems combined with pay-for-performance for chronic disease management including diabetes, helps to ensure population-wide data.

The extraction software will permit validation of the extracted data by primary care staff prior to transfer to the research team.

Using HbA1c results only to define new-onset diabetes means this study is not impacted by the quality of diabetes diagnosis coding in primary care.

This study will raise awareness of new-onset diabetes’ association with pancreatic cancer within the primary care community.

The study period includes the COVID-19 pandemic, thus the data within this period may not reflect data obtained before or after the pandemic.