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FältnamnIndikatorerMetadata
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001oai:DiVA.org:hj-64311
003SwePub
008240527s2024 | |||||||||||000 ||eng|
009oai:DiVA.org:oru-113693
024a https://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-643112 URI
024a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-1136932 URI
040 a (SwePub)hjd (SwePub)oru
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a Fejrskov, Anjau 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, Denmark4 aut
2451 0a Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease :b protocol for the Nordic inception cohort study (NORDTREAT)
264 1b BioMed Central (BMC),c 2024
338 a print2 rdacarrier
500 a Protocol.
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Gastroenterologi0 (SwePub)302132 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Gastroenterology and Hepatology0 (SwePub)302132 hsv//eng
653 a Adult gastroenterology
653 a Endoscopy
653 a Gastroenterology
653 a Inflammatory bowel disease
653 a Prognosis
700a Füchtbauer, Johannes Davidu Department 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, Denmark4 aut
700a Davíðsdóttir, Lóa Gu Department of Gastroenterology, Landspitali National University Hospital of Iceland, Reykjavik, Iceland4 aut
700a Halfvarson, Jonas,d 1970-u Department of Internal Medicine, Örebro University Hospital, Örebro, Region Örebro län, Sweden4 aut0 (Swepub:oru)jshn
700a Høivik, Marte Lieu Department of Gastroenterology, Oslo University Hospital, Oslo, Norway; University of Oslo Institute for Clinical Medicine, Oslo, Norway4 aut
700a Jensen, Michael Damu 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, Denmark4 aut
700a Mortensen, Joachim Høgu Gastrointestinal Diseases, Nordic Bioscience A/S, Herlev, Denmark4 aut
700a Nielsen, Lene Nyholmu Research Unit of Medical Gastroenterology and Hepatology, Hospital South West Jutland, Esbjerg, Denmark4 aut
700a Rejler, Martinu Jönköping 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, Sweden4 aut
700a Repsilber, Dirk,d 1971-u Örebro universitet,Institutionen för medicinska vetenskaper,School of Health and Medical Sciences, Örebro University, Örebro, Sweden4 aut0 (Swepub:oru)drr
700a Söderholm, Johan D.u Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Östergötland, Sweden4 aut
700a Aalykke, Clausu Internal Medicine and Emergency Department, Odense University Hospital, Svendborg, Denmark4 aut
700a Andersen, Vibekeu 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, Denmark4 aut
700a Christensen, Robinu Section for Biostatistics and Evidence-Based Research, Parker Institute, Frederiksberg, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark4 aut
700a Kjeldsen, Jensu Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; Research Unit of Medical Gastroenterology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark4 aut
710a 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, Denmarkb Department 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, Denmark4 org
773t BMJ Opend : BioMed Central (BMC)g 14:5q 14:5x 2044-6055
856u https://doi.org/10.1136/bmjopen-2023-083144y Fulltext
856u https://bmjopen.bmj.com/content/14/5/e083144.longy Publisher's fulltext
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-64311
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-113693

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