Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT)
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ. Publisher Copyright: © 2024 BMJ Publishing Group. All rights reserved. INTRODUCTION: Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, can be challenging to diagnose, and t...
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Online Access: | https://hdl.handle.net/20.500.11815/4932 https://doi.org/10.1136/bmjopen-2023-083144 |
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Opin vísindi (Iceland) |
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Meltingarlæknisfræði Humans Biomarkers Crohn Disease/diagnosis Inflammatory Bowel Diseases/diagnosis Longitudinal Studies Multicenter Studies as Topic Prognosis Prospective Studies Research Design Scandinavian and Nordic Countries Inflammatory bowel disease Gastroenterology Adult gastroenterology Endoscopy General Medicine |
spellingShingle |
Meltingarlæknisfræði Humans Biomarkers Crohn Disease/diagnosis Inflammatory Bowel Diseases/diagnosis Longitudinal Studies Multicenter Studies as Topic Prognosis Prospective Studies Research Design Scandinavian and Nordic Countries Inflammatory bowel disease Gastroenterology Adult gastroenterology Endoscopy General Medicine Fejrskov, Anja Füchtbauer, Johannes David Davíðsdóttir, Lóa Guðrún Halfvarson, Jonas Høivik, Marte Lie Jensen, Michael Dam Mortensen, Joachim Høg Nielsen, Lene Nyholm Rejler, Martin Repsilber, Dirk Söderholm, Johan D Aalykke, Claus Andersen, Vibeke Christensen, Robin Kjeldsen, Jens Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) |
topic_facet |
Meltingarlæknisfræði Humans Biomarkers Crohn Disease/diagnosis Inflammatory Bowel Diseases/diagnosis Longitudinal Studies Multicenter Studies as Topic Prognosis Prospective Studies Research Design Scandinavian and Nordic Countries Inflammatory bowel disease Gastroenterology Adult gastroenterology Endoscopy General Medicine |
description |
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ. Publisher Copyright: © 2024 BMJ Publishing Group. All rights reserved. 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 ... |
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Article in Journal/Newspaper |
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Fejrskov, Anja Füchtbauer, Johannes David Davíðsdóttir, Lóa Guðrún Halfvarson, Jonas Høivik, Marte Lie Jensen, Michael Dam Mortensen, Joachim Høg Nielsen, Lene Nyholm Rejler, Martin Repsilber, Dirk Söderholm, Johan D Aalykke, Claus Andersen, Vibeke Christensen, Robin Kjeldsen, Jens |
author_facet |
Fejrskov, Anja Füchtbauer, Johannes David Davíðsdóttir, Lóa Guðrún Halfvarson, Jonas Høivik, Marte Lie Jensen, Michael Dam Mortensen, Joachim Høg Nielsen, Lene Nyholm Rejler, Martin Repsilber, Dirk Söderholm, Johan D Aalykke, Claus Andersen, Vibeke Christensen, Robin Kjeldsen, Jens |
author_sort |
Fejrskov, Anja |
title |
Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) |
title_short |
Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) |
title_full |
Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) |
title_fullStr |
Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) |
title_full_unstemmed |
Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) |
title_sort |
novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the nordic inception cohort study (nordtreat) |
publishDate |
2024 |
url |
https://hdl.handle.net/20.500.11815/4932 https://doi.org/10.1136/bmjopen-2023-083144 |
genre |
Iceland |
genre_facet |
Iceland |
op_relation |
BMJ Open; 14(5) http://www.scopus.com/inward/record.url?scp=85193451368&partnerID=8YFLogxK Fejrskov , A , Füchtbauer , J D , Davíðsdóttir , L G , Halfvarson , J , Høivik , M L , Jensen , M D , Mortensen , J H , Nielsen , L N , Rejler , M , Repsilber , D , Söderholm , J D , Aalykke , C , Andersen , V , Christensen , R & Kjeldsen , J 2024 , ' Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) ' , BMJ Open , vol. 14 , no. 5 , e083144 , pp. e083144 . https://doi.org/10.1136/bmjopen-2023-083144 2044-6055 222995237 bde1398e-62df-49f3-95f3-eb235fbf37ca 38754881 PubMedCentral: PMC11097809 85193451368 unpaywall: 10.1136/bmjopen-2023-083144 https://hdl.handle.net/20.500.11815/4932 doi:10.1136/bmjopen-2023-083144 |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/20.500.11815/493210.1136/bmjopen-2023-083144 |
container_title |
BMJ Open |
container_volume |
14 |
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ftopinvisindi:oai:opinvisindi.is:20.500.11815/4932 2024-09-15T18:14:42+00:00 Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) Fejrskov, Anja Füchtbauer, Johannes David Davíðsdóttir, Lóa Guðrún Halfvarson, Jonas Høivik, Marte Lie Jensen, Michael Dam Mortensen, Joachim Høg Nielsen, Lene Nyholm Rejler, Martin Repsilber, Dirk Söderholm, Johan D Aalykke, Claus Andersen, Vibeke Christensen, Robin Kjeldsen, Jens Other departments 2024-05-15 13617096 e083144 https://hdl.handle.net/20.500.11815/4932 https://doi.org/10.1136/bmjopen-2023-083144 en eng BMJ Open; 14(5) http://www.scopus.com/inward/record.url?scp=85193451368&partnerID=8YFLogxK Fejrskov , A , Füchtbauer , J D , Davíðsdóttir , L G , Halfvarson , J , Høivik , M L , Jensen , M D , Mortensen , J H , Nielsen , L N , Rejler , M , Repsilber , D , Söderholm , J D , Aalykke , C , Andersen , V , Christensen , R & Kjeldsen , J 2024 , ' Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease : protocol for the Nordic inception cohort study (NORDTREAT) ' , BMJ Open , vol. 14 , no. 5 , e083144 , pp. e083144 . https://doi.org/10.1136/bmjopen-2023-083144 2044-6055 222995237 bde1398e-62df-49f3-95f3-eb235fbf37ca 38754881 PubMedCentral: PMC11097809 85193451368 unpaywall: 10.1136/bmjopen-2023-083144 https://hdl.handle.net/20.500.11815/4932 doi:10.1136/bmjopen-2023-083144 info:eu-repo/semantics/openAccess Meltingarlæknisfræði Humans Biomarkers Crohn Disease/diagnosis Inflammatory Bowel Diseases/diagnosis Longitudinal Studies Multicenter Studies as Topic Prognosis Prospective Studies Research Design Scandinavian and Nordic Countries Inflammatory bowel disease Gastroenterology Adult gastroenterology Endoscopy General Medicine /dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article 2024 ftopinvisindi https://doi.org/20.500.11815/493210.1136/bmjopen-2023-083144 2024-06-24T23:36:56Z © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ. Publisher Copyright: © 2024 BMJ Publishing Group. All rights reserved. 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 ... Article in Journal/Newspaper Iceland Opin vísindi (Iceland) BMJ Open 14 5 e083144 |