Jens Kjeldsen
Jens Kjeldsen
Department of Medical Gastroenterology
| Project management | ||
| Project status | Open | |
| Data collection dates | ||
| Start | 01.01.2021 | |
| End | 30.06.2025 | |
NORDTREAT: The Nordic IBD treatment strategy trial - a randomized controlled trial of access to a protein profile
Short summary
Inflammatory bowel disease (IBD) manifests with varying severity between individuals. The absence of reliable prognostic markers challenge disease management. Conventional 'step-up' therapy may undertreat patients with aggressive disease, while a 'top-down' approach could expose patients with indolent disease to unnecessary treatment-related toxicity.
Rationale
The NORDTREAT study aims to assess if stratification of patients based on a prognostic serum protein signature at diagnosis can deliver personalised therapy and improve treatment outcomes by treating patients with an increased risk of poor disease course with a top-down treatment. Also, the trial will assess if this treatment strategy is safe and can improve quality of life and health resource allocation in IBD patients with a high risk of poor disease course, defined by the serum protein signature.
Description of the cohort
Patients with newly diagnosed inflammatory bowel disease. Cohort of patients included in Denmark, Sweden, Norway and Iceland.
Data and biological material
Blood samples at inclusion for serum protein signature