Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease: protocol for the Nordic inception cohort study (NORDTREAT)Department of Gastroenterology, Oslo University Hospital, Oslo, Norway; University of Oslo Institute for Clinical Medicine, Oslo, Norway.
Department of Internal Medicine-Gastroenterology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark; Institute of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
Gastrointestinal Diseases, Nordic Bioscience A/S, Herlev, Denmark.
Research Unit of Medical Gastroenterology and Hepatology, Hospital South West Jutland, Esbjerg, Denmark.
Jönköping Academy for Improvement in Health and Welfare, Jönköping University, Jönköping, Sweden; Futurum-Academy for Healthcare, Futurum Academy of Health and Care, Jönköping, Region Jönköping County, Sweden.
Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Östergötland, Sweden.
Internal Medicine and Emergency Department, Odense University Hospital, Svendborg, Denmark.
Department of Internal Medicine, Molecular Diagnostics and Clinical Research Unit, Institute of Regional Health Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Odense, Denmark; OPEN, Open Patient data Explorative Network, University of Southern Denmark, Odense, Denmark.
Section for Biostatistics and Evidence-Based Research, Parker Institute, Frederiksberg, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Research Unit of Medical Gastroenterology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
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2024 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 14, no 5, article id e083144
Article in journal (Refereed) Published
Abstract [en]
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.
Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2024. Vol. 14, no 5, article id e083144
Keywords [en]
Adult gastroenterology, Endoscopy, Gastroenterology, Inflammatory bowel disease, Prognosis
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:oru:diva-113693DOI: 10.1136/bmjopen-2023-083144ISI: 001276395700057PubMedID: 38754881Scopus ID: 2-s2.0-85193451368OAI: oai:DiVA.org:oru-113693DiVA, id: diva2:1859382
Note
Study protocol
The NORDTREAT project has received funding from NordForsk (30 000 000 SKR) via Vinnova (grant number 2019-01185 NORDTREAT), Rannis (NordForsk no. 90569-grant no. 199782-0611), The Research Council of Norway (grant no. 2988039) and Innovation Fund Denmark (90569 NORDTREAT: grant number 8114-00026B). The Danish partners have allocated the funding (4 800 000 DKR) for remuneration of project staff, biobanking and analyses of biological material. Furthermore, the University Hospital of Southern Denmark, Hospital Sønderjylland has funded 1 125 000 DKR for PhD salary (Fejrskov A (grant number not applicable)), The Region of Southern Denmark (Fri og Strategisk Forskning) has funded 1 137 000 DKR (Fejrskov A (J.no.: 21/17578 and Efond: 1084) and Füchtbauer JD (grant number A1381)) for biobanking and analyses of biological material. Knud and Edith Eriksen Memorial Fund has funded 75 000 DKR for PhD salary (Fejrskov A (case no. 62786-2022)). Odense University Hospital has funded 584 000 DKR for PhD salary (Füchtbauer JD (grant number A5031)). Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital (Christensen R) is supported by a core grant from the Oak Foundation (OCAY-13-309).
2024-05-212024-05-212025-01-20Bibliographically approved