© Neeraj Narula
The primary objective of this study is to identify novel serum biomarkers prior to IBD onset that may mediate IBD risk in PURE.
The proposed study is a prospective case-cohort study of approximately 12,000 participants (of whom 109 developed IBD) in PURE who participated in a biomarker sub-study initiated in 2018. All participants had serum samples at baseline and had extensive biomarker assessments performed. Biomarkers will be compared between the IBD and non-IBD cohorts. A total of 982 biomarkers will be analysed using proximity extension assays, of which the top five with the strongest signals will be analysed further in the validation cohort of 111 IBD patients and matched controls.
It has been hypothesised that IBD, as an immune-mediated disease, has an asymptomatic pre-clinical phase. Our study presents a unique opportunity to identify biomarkers in pre-disease states for earlier detection of disease onset. The study will add to the existing knowledge generated by the PREDICTS study to inform the development of a multifaceted predictive tool for identification of individuals who are at high risk of developing IBD, which takes into consideration clinical data and biomarker and genetic findings.
An approximate timeline of study events includes: