Claridge, H; Price, C A; Ali, R; Cooke, E A; de Lusignan, S; Harvey-Sullivan, A; Hodges, C; Khalaf, N; O'Callaghan, D; Stunt, A; Thomas, S A; Thomson, J; Lemanska, A (2024) Determing the feasibility of calculating pancreatic cancer risk scores for people with new-onset diabetes in primary care (DEFEND PRIME): study protocol. BMJ Open, 14 (1). e079863

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Abstract

Introduction

Worldwide, pancreatic cancer has a poor prognosis. Earlier diagnosis may improve survival by enabling curative treatment. However, non-specific symptoms and a lack of suitable biomarkers make this challenging. Statistical and machine learning prediction models using risk factors such as patient demographics, symptoms and blood tests are being developed for clinical use to improve earlier 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. However, ENDPAC has yet to be used in clinical settings. In the United Kingdom (UK), blood tests and weight measurements are routinely collected in primary care which, given primary care’s central role in assessing and addressing patients’ cancer risk, makes it an ideal setting to assess ENDPAC’s feasibility.

Methods and analysis

DEFEND PRIME will be a multi-centre observational study determining the feasibility of extracting data from primary care providers in the UK to calculate ENDPAC scores. After developing the data extraction methods, 20 UK GP practices will provide anonymised data on participants aged 50+ years, with a glycated haemoglobin (HbA1c) test result of ≥ 48 mmol/mol and no previous abnormal HbA1c results. ENDPAC scores will be calculated, and descriptive statistics used to summarise the cohort’s demographics and assess data quality. Findings will inform the development of a future clinical study, in which ENDPAC scores will be calculated and participants with elevated scores will be invited for clinical workup.

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 GP practices, clinical leads and policy makers will be provided with summaries of the findings.

Item Type:	Article
Keywords:	Primary care, primary health care, pancreatic disease, gastroenterology, electronic health records, feasibility studies, protocols and guidelines, health services administration and management
Subjects:	Mathematics and Scientific Computing > Software Engineering
Divisions:	Data Science
Identification number/DOI:	10.1136/bmjopen-2023-079863
Last Modified:	15 Apr 2024 14:26
URI:	https://eprintspublications.npl.co.uk/id/eprint/9965