The Nordic IBD Study Within Personalized Medicine - Diagnosing and Prediction Using Molecular Characterization of Inflammatory Bowel Disease: the NORDTREAT Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 34
- 主要终点
- Improving the accuracy to diagnose IBD
研究概览
简要总结
Inflammatory bowel disease (IBD), primarily ulcerative colitis (UC) and Crohn's disease (CD), is a chronic disease entity affecting individuals of all ages, and which may severely impact the lives of the patients and their families as well as society. Individuals with IBD may have to live with relapsing symptoms, such as diarrhea, abdominal pain, and fatigue. Further, a substantial proportion of patients develop serious complications such as bowel obstruction and fistula, and some develop complicating liver disease and eventually colorectal cancer. The consequences are that many patients suffer hospitalizations, recurring sick-leave, life-long medication, and surgical interventions. As IBD has become increasingly common in Western populations there is a clear need to improve the outcome from IBD.
IBD is a heterogeneous disease entity with substantial differences between patients and personalized medicine may help provide strategies for better treatment . Currently, one of the main unmet needs is the glaring lack of robust biomarkers for individual disease characterization. This lack leads to delayed diagnosis, worse outcomes, increased mortality and an amplified disease burden. Furthermore, diagnosis of IBD is difficult and early diagnosis is crucial as it helps avoid the development of irreversible organ damage. Therefore, there is an emerging focus on the development of simple, non-invasive, and cheap biomarkers to support clinical decision-making in IBD.
This Nordic, prospective, clinical study has the aim of identifying markers that are associated with the diagnosis of IBD and prediction of clinical outcomes with various disease manifestations. Importantly, this study will evaluate the markers in a relevant clinical setting, i.e. among patients referred to the hospital for suspicion on IBD using the ECCO Criteria.
Specifically the aims of the study are to:
- Improve the accuracy to diagnose IBD
- Improve the accuracy to define the prognosis of IBD
The study is approved by the local Ethics Committee (S-20200051) and the local Data Agency (20/54594).
详细描述
The primary aim is to identify molecular markers (e.g. in the blood and stools) for discrimination between individuals diagnosed with inflammatory bowel disease (IBD) inclusive Crohn's disease (CD), ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBD-U), and those without (non-IBD). Participants with suspected IBD at baseline, with various disease pathways, will be evaluated again using a 1-year cohort study. Diagnosis and clinical outcome will be evaluated at referral and after 1 year of observation.
The secondary aims are, in addition to the molecular information, to investigate whether the inclusion of information on clinical and lifestyle factors as well as combination hereof (e.g. gene-environment interaction analyses) can improve the predictive potential of identifying IBD and distinguish the prognosis.
Study design: A prospective Nordic multicenter study on prognostic factors for the diagnosis and characterization of IBD among patients referred to the hospital on suspicion of IBD. A panel of possible prognostic biomarkers for diagnostic purposes will be applied to all participants.
Setting: All patients referred due to a suspicion of IBD to the departments of gastroenterology in Odense University Hospital, Svendborg Hospital, Vejle Hospital, Esbjerg Hospital and potentially Hospital of Southern Jutland, Aabenraa will be invited to take part in the study. Participants will be included from January 2022 for a 1-year period or until 800 participants in the Nordic study (up to 400 in Denmark) have been included. The follow-up period is one-year including visits and questionnaires and an additional nine years of follow-up by the use of register data. Biological material will be obtained four times for participants with IBD, at week-2/0, and 12, 26 and 52 after the diagnosis has been established. Participants where IBD is not established (non-IBD) will only have biological material obtained at baseline (that is visit -2/0) and will have a clinical interview after 52 weeks. All participants are treated according to standard clinical practice by the clinical departments.
Clinical data consist of personal data, data on health and disease, lifestyle, laboratory measures, and disease activity scores including patient-reported outcome measures (PROMs), clinical assessments, and laboratory data. Each participant will fill out validated questionnaires on disease activity, quality of life, and lifestyle using electronic links.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the study, the participants must meet the following criteria:
- •Inclusion Criteria:
- •Referred on the suspicion of inflammatory bowel disease
- •Adult (+18 years of age)
- •Written informed consent to participate in the study
排除标准
- •A previous known diagnosis of Crohn's disease, ulcerative colitis or IBD-U
- •Unable to provide informed consent
- •Unable to comply with protocol requirements (e.g., for reasons including alcohol and/or recreational drug abuse)
结局指标
主要结局
Improving the accuracy to diagnose IBD
时间窗: Baseline (Week 0) and Week 52
The primary endpoint in the cross-sectional study will be diagnosis, i.e., IBD (including CD, UC, IBD-U) or non-IBD (patients that are not diagnosed with IBD) at referral. IBD is diagnosed according to the ECCO criteria based on endoscopic, histologic and/or radiological criteria.
Improving the accuracy to define prognosis of IBD
时间窗: Week 52
The primary endpoint in the longitudinal cohort study will be severe IBD at week 52 defined as: * IBD-related surgery or * IBD-related hospitalization (except planned procedures) or * IBD-related death
次要结局
- Surgery in CD due to obstructive symptoms (stenosis)(Week 52)
- Lack of corticosteroid-free clinical remission at week 12*(Week 12)
- Lack of corticosteroid-free endoscopic healing at week 52*(Week 52)
- Disease impact on patients life(Week 52)
- Disease impact on patients life (daily functioning and quality of life)(Week 52)
- Disease impact on patients life (perception of health)(Week 52)
- Long-term complications(Week 52)
- Disease impact on patients life (fecal incontinence)(Week 52)
- Fatigue Questionnaire(Week 52)
- Flares(Week 52)
- Mid-term complications(Week 52)
- Anxiety and depression(Week 52)
- Glucocorticoid exposures(Week 52)
- Adverse drug reactions(Week 52)
- Increased faecal calprotectin at week 52(Week 52)
- Time to start of biological therapy(Week 52)
- Time to onset of event (IBD-related surgery or IBD-related hospitalization)(Week 52)
- The composite secondary outcome of the proportion of patients who experience severe IBD within 52 weeks after inclusion(Week 52)