跳至主要内容
临床试验/NCT04748627
NCT04748627招募中不适用

Global IBD Visualization of Epidemiology Studies (GIVES) in the 21st Century (GIVES-21)

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Incidence of IBD

研究概览

简要总结

Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) of unknown etiology. The pathophysiology of IBD relates to the mucosal immune response to antigenic stimulation from the gut microbiota secondary to environmental influence, on a background of genetic susceptibility. IBD represents an important public health problem because it affects mostly young people at an age when they are most active in their private and professional life, and a management challenge because of its unpredictable relapsing nature. During the last few decades the incidence of IBD has changed in many ways. Incidence rates of traditionally high incidence areas such as the United States and Europe is remaining relatively stable or even decreasing, while the diseases have become more prevalent in previously low incidence areas, including Asia. Our latest systematic review has demonstrated that the highest reported prevalence of IBD was still in Europe and North America, however, the incidence of IBD has been rising in newly industrialized countries since 1990.

详细描述

Investigators aim to study the incidence, demographic factors, and disease outcomes of IBD patients, environmental and dietary factors associated with IBD in 19 regions globally. Via the web registration, investigators intend to form a new prospective, uniformly diagnosed, population-based inception cohort of patients with IBD. Physicians, gastroenterologists, family doctors, surgeons and pathologists in the study area will be notified repeatedly about the study by letter, telephone, internet, personal visit of the investigators, and encouraged to inform investigators of every possible new case of IBD. Endoscopic, pathology and radiology records will be canvassed repeatedly for likely cases, both electronically and manually. By these methods, investigators intend to capture over 90% of possible cases. All patients are required to meet the diagnostic criteria for IBD on the basis of clinical symptoms, endoscopic or radiological evidence or mucosal biopsies. Infectious gastroenteritis, tuberculosis, entamoeba and cancer have to be ruled out. The web-based database application will be used for online registration of the various registration forms and questionnaires and the database is located on a central secured server. With the data collected, an online interactive atlas will be created which allows the community to visualize the most up-to-date epidemiology of IBD with the aims to promotes knowledge translation and research endeavours of stakeholders and provide infrastructure, resources, and expertise to define Crohn's disease burden in regions of the world where the disease is emerging.

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

入选标准

  • Aged ≥ 18 years old
  • Confirmed diagnosis of Crohn's disease or Ulcerative Colitis according to established clinical, endoscopic and histological criteria
  • Written informed consent obtained

排除标准

  • For healthy control:
  • Inclusion criteria:
  • Aged ≥ 18 years old
  • Asymptomatic
  • Written informed consent obtained
  • Exclusion Criteria:
  • Diagnosis of any chronic medical illnesses.

结局指标

主要结局

Incidence of IBD

时间窗: 1 year

To determine the incidence of IBD in 19 regions globally, and to investigate if this increase is caused by environmental and dietary factors.

次要结局

  • Geographical effect(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siew Chien NG

Professor

Chinese University of Hong Kong

研究点 (1)

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