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.
Competing Interest StatementJT's role in Surrey and Sussex Cancer Alliance is part funded by Cancer Research UK.
Funding StatementThis research was conducted as part of a PhD studentship funded by the University of Surrey and undertaken by HC. This study received seed funding from the Faculty of Health and Medical Sciences, University of Surrey awarded to AL.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The University Ethics Committee of the University of Surrey gave ethical approval for this work.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityData extracts created as part of this project will remain under the management of GP practices. Data will not be made open access or deposited in any repository, as outlined in the data sharing agreement. Subject to all necessary approvals, data may be made available for secondary use by the GP practices who remain data controllers.
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