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Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease: protocol for the Nordic inception cohort study (NORDTREAT)

Authors :
Jonas Halfvarson
Robin Christensen
Vibeke Andersen
Jens Kjeldsen
Marte Lie Hoivik
Claus Aalykke
Johan D Söderholm
Anja Fejrskov
Johannes David Füchtbauer
Lóa G Davíðsdóttir
Michael Dam Jensen
Joachim Høg Mortensen
Lene Nyholm Nielsen
Martin Rejler
Dirk Repsilber
Source :
BMJ Open, Vol 14, Iss 5 (2024)
Publication Year :
2024
Publisher :
BMJ Publishing Group, 2024.

Abstract

Introduction Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, can be challenging to diagnose, and treatment outcomes are difficult to predict. In the NORDTREAT cohort study, a Nordic prospective multicentre study, we aim to identify novel molecular biomarkers of diagnostic value by assessing the diagnostic test accuracy (cross-sectionally), as well as the prognostic utility when used as prognostic markers in the long-term (cohort study). In the diagnostic test accuracy study, the primary outcome is a successful diagnosis using one or more novel index tests at baseline compared with the ECCO criteria as the reference standard. The composite outcome of the prognostic utility study is ‘severe IBD’ within 52 weeks from inclusion, defined as one or more of the following three events: IBD-related surgery, IBD-related hospitalisation or IBD-related death.Methods and analysis We aim to recruit 800 patients referred on suspicion of IBD to this longitudinal observational study, a collaboration between 11 inclusion sites in Denmark, Iceland, Norway and Sweden. Inclusion will occur from February 2022 until December 2023 with screening and baseline visits for all participants and three outcome visits at weeks 12, 26 and 52 after baseline for IBD-diagnosed patients. Biological material (blood, faeces, biopsies, urine and hair), clinical data and lifestyle information will be collected during these scheduled visits.Ethics and dissemination This study will explore novel biomarkers to improve diagnostic accuracy and prediction of disease progression, thereby improving medical therapy and the quality of life for patients with IBD.The study is approved by the Ethics Committee (DK: S-20200051, v1.4, 16.10.2021; IS: VSNb2021070006/03.01, NO: 193064; SE: DNR 2021-05090) and the Danish Data Protecting Agency (20/54594). Results will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.Clinical trial registration number NCT05414578; Pre-results.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
14
Issue :
5
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.1f2f1480c9e74af989e1ef25d51dcec0
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2023-083144