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  • Fejrskov, AnjaDepartment of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Department of Internal Medicine, Molecular Diagnostics and Clinical Research Unit, Institute of Regional Health Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Section for Biostatistics and Evidence-Based Research, Parker Institute, Frederiksberg, Denmark (author)

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

  • Article/chapterEnglish2024

Publisher, publication year, extent ...

  • BioMed Central (BMC),2024
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:hj-64311
  • https://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-64311URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-113693URI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Protocol.
  • 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.

Subject headings and genre

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  • Füchtbauer, Johannes DavidDepartment of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Research Unit of Medical Gastroenterology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Internal Medicine and Emergency Department, Odense University Hospital, Svendborg, Denmark (author)
  • Davíðsdóttir, Lóa GDepartment of Gastroenterology, Landspitali National University Hospital of Iceland, Reykjavik, Iceland (author)
  • Halfvarson, Jonas,1970-Department of Internal Medicine, Örebro University Hospital, Örebro, Region Örebro län, Sweden(Swepub:oru)jshn (author)
  • Høivik, Marte LieDepartment of Gastroenterology, Oslo University Hospital, Oslo, Norway; University of Oslo Institute for Clinical Medicine, Oslo, Norway (author)
  • Jensen, Michael DamDepartment 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 (author)
  • Mortensen, Joachim HøgGastrointestinal Diseases, Nordic Bioscience A/S, Herlev, Denmark (author)
  • Nielsen, Lene NyholmResearch Unit of Medical Gastroenterology and Hepatology, Hospital South West Jutland, Esbjerg, Denmark (author)
  • Rejler, MartinJönköping University,The Jönköping Academy for Improvement of Health and Welfare,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 (author)
  • Repsilber, Dirk,1971-Örebro universitet,Institutionen för medicinska vetenskaper,School of Health and Medical Sciences, Örebro University, Örebro, Sweden(Swepub:oru)drr (author)
  • Söderholm, Johan D.Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Östergötland, Sweden (author)
  • Aalykke, ClausInternal Medicine and Emergency Department, Odense University Hospital, Svendborg, Denmark (author)
  • Andersen, VibekeDepartment 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 (author)
  • Christensen, RobinSection for Biostatistics and Evidence-Based Research, Parker Institute, Frederiksberg, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark (author)
  • Kjeldsen, JensDepartment of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Research Unit of Medical Gastroenterology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark (author)
  • Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Department of Internal Medicine, Molecular Diagnostics and Clinical Research Unit, Institute of Regional Health Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Section for Biostatistics and Evidence-Based Research, Parker Institute, Frederiksberg, DenmarkDepartment of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Research Unit of Medical Gastroenterology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Internal Medicine and Emergency Department, Odense University Hospital, Svendborg, Denmark (creator_code:org_t)

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