Verification and validation of a biomarker panel that identifies individuals at high risk to develop Crohn’s disease allowing INTERCEPTION of full-blown disease development

Chronic inflammatory diseases such rheumatoid arthritis (RA), multiple sclerosis (MS), type 1 diabetes (t1D) and Crohn’s disease (CD) are increasingly common and cause important loss of quality of life and work productivity. Most of these conditions are diagnosed at a late stage of the disease; many patients have complications at diagnosis. For many of these conditions there are now methods or markers in the blood that allow diagnosis in the preclinical phase, meaning that individuals can be identified that have the disease but not yet the symptoms. This would allow very early treatment (which is highly effective) that prevents development of complications, which has been done successfully in RA, MS and t1D. CD mainly affects adolescents/young adults in the most productive phase of life. At diagnosis the majority of patients has fistulas (painful holes around the anus), stenosis of the bowel leading to crampy pain and metabolic symptoms such as weight loss, iron deficiency and other nutritional deficiencies. In CD, a number of molecules (‘markers’) have been identified in the blood of individuals up to 7 years before diagnosis. In the current project we wish to verify these markers in North American and European cohorts of which we have the serum available in freezers with the help of advanced laboratory tests leading to a ‘serum signature’. An algorithm will incorporate the relative importance of the different proteins to make it ready for widespread use. Then, we will test this signature in 10000 first degree relatives of European patients with CD across 7 countries, a process that is named ‘prospective validation’. In a final step we will demonstrate that if individuals are identified with the biomarker, CD symptom development can be halted (‘intercepted’) with medical treatment. If we succeed in this scientific work, the impact for the community would be enormous. We would be able to prevent suffering, surgeries, disability and loss of productivity significantly.