TY - JOUR
T1 - Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease
T2 - protocol for the Nordic inception cohort study (NORDTREAT)
AU - Severino, Anja Fejrskov
AU - Fuchtbauer, David
AU - Davíðsdóttir, Lóa G
AU - Halfvarson , Jonas
AU - Lie Høivik, Marte
AU - Jensen, Michael Dam
AU - Høg Mortensen, Joachim
AU - Nyholm Nielsen, Lene
AU - Rejler, Martin
AU - Repsilber, Dirk
AU - D Söderholm , Johan
AU - Aalykke, Claus
AU - Andersen, Vibeke
AU - Christensen, Robin
AU - Kjeldsen, Jens
PY - 2024/5/15
Y1 - 2024/5/15
N2 - 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.
AB - 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.
KW - Adult gastroenterology
KW - Endoscopy
KW - Gastroenterology
KW - Inflammatory bowel disease
KW - Prognosis
KW - Inflammatory Bowel Diseases/diagnosis
KW - Prospective Studies
KW - Humans
KW - Scandinavian and Nordic Countries
KW - Multicenter Studies as Topic
KW - Crohn Disease/diagnosis
KW - Biomarkers
KW - Longitudinal Studies
KW - Research Design
U2 - 10.1136/bmjopen-2023-083144
DO - 10.1136/bmjopen-2023-083144
M3 - Journal article
C2 - 38754881
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e083144
ER -