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.
BMJ Open. 2024 May 15;14(5):e083144. doi: 10.1136/bmjopen-2023-083144.
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.
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.
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.
NCT05414578; Pre-results.
炎症性肠病（IBD），包括溃疡性结肠炎和克罗恩病，诊断具有挑战性，治疗效果难以预测。在北欧特疗（NORDTREAT）队列研究中，这是一项北欧前瞻性多中心研究，我们旨在通过评估诊断测试的准确性（横截面），以及将其作为长期预后标志物的预后效用，来确定具有诊断价值的新型分子生物标志物。在诊断测试准确性研究中，主要结局是在基线时使用一种或多种新型指标测试成功诊断，以 ECCO 标准作为参考标准。预后效用研究的复合结局是纳入后 52 周内“严重 IBD”，定义为以下三个事件之一或多个：IBD 相关手术、IBD 相关住院或 IBD 相关死亡。
我们计划招募 800 名因怀疑患有 IBD 而转介的患者参与这项纵向观察性研究，该研究是丹麦、冰岛、挪威和瑞典的 11 个纳入点之间的合作。纳入将从 2022 年 2 月持续到 2023 年 12 月，对所有参与者进行筛查和基线访视，并对 IBD 确诊患者在基线后 12、26 和 52 周进行 3 次结局访视。在这些预定访视期间将收集生物材料（血液、粪便、活检、尿液和头发）、临床数据和生活方式信息。
这项研究将探索新型生物标志物，以提高诊断准确性和疾病进展预测，从而改善 IBD 患者的医疗治疗和生活质量。该研究已获得伦理委员会（丹麦：S-20200051，v1.4，2021 年 10 月 16 日；冰岛：VSNb2021070006/03.01；挪威：193064；瑞典：DNR 2021-05090）和丹麦数据保护局（20/54594）的批准。结果将通过同行评议的期刊、患者协会和国际会议上的演讲进行传播。
NCT05414578；预结果。
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