背景:炎症性肠病(IBD),包括溃疡性结肠炎和克罗恩病,诊断可能很有挑战性,治疗结果难以预测。在NORDTREAT队列研究中,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)来鉴定具有诊断价值的新型分子生物标志物,以及在长期(队列研究)中用作预后标志物时的预后效用。在诊断测试准确性研究中,与作为参考标准的ECCO标准相比,主要结局是在基线时使用一项或多项新型指数测试成功诊断.预后效用研究的复合结局是“严重IBD”在纳入后52周内,定义为以下三个事件中的一个或多个:IBD相关手术,IBD相关住院或IBD相关死亡。
方法:我们的目标是招募800名怀疑IBD的患者参与这项纵向观察研究,丹麦11个收录网站之间的合作,冰岛,挪威和瑞典。纳入将于2022年2月至2023年12月进行,所有参与者的筛查和基线访问以及IBD诊断患者基线后第12、26和52周的3次结果访问。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将在这些定期访视期间收集.
背景: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的预测,从而改善IBD患者的药物治疗和生活质量。本研究得到伦理委员会(DK:S-20200051,v1.4,16.10.2021;IS:VSNb2021070006/03.01,NO:193064;SE:DNR2021-05090)和丹麦数据保护机构(20/54594)的批准。结果将通过同行评审的期刊传播,患者协会和在国际会议上的演讲。
背景:NCT05414578;预结果。
BACKGROUND: 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: 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.
BACKGROUND: 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.
BACKGROUND: NCT05414578; Pre-results.