Long-term Observation of IBD Patients, a Nationwide German IBD Registry "CEDUR"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
The CEDUR registry systematically collects real-world data on inflammatory bowel disease (IBD) patients in Germany. The registry aims to assess quality of care, disease activity, treatment effectiveness, safety, and pharmacoeconomic aspects under routine clinical conditions.
详细描述
CEDUR is a multicenter, web-based, observational registry for adult IBD patients in Germany. The registry includes Crohn's disease, ulcerative colitis, and indeterminate colitis. Data are collected prospectively from physicians and patients, covering clinical parameters, quality of life, treatment patterns, and safety outcomes. The registry supports the evaluation of care quality, cost-effectiveness, and long-term therapy outcomes under real-life conditions.
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
- •Crohn Disease Ulcerative Colitis Indterminate Colitis
排除标准
- •Other gastrointestinal disorders than above
结局指标
主要结局
Crohn's Disease Activity Index (CDAI)
时间窗: Up to 10 years of follow-up
The Crohn's Disease Activity Index (CDAI) is a composite clinical score assessing disease activity in patients with Crohn's disease. It incorporates eight variables including stool frequency, abdominal pain, general well-being, extraintestinal manifestations, and laboratory parameters. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity.
Partial Mayo Score
时间窗: Up to 10 years of follow-up
The Partial Mayo Score is a clinical index used to assess disease activity in ulcerative colitis. It includes stool frequency, rectal bleeding, and physician's global assessment, with scores ranging from 0 to 9. Higher scores indicate more severe disease activity.
Mayo Score (Full Mayo Score)
时间窗: Up to 10 years of follow-up
The Mayo Score is a composite index used to assess disease activity in ulcerative colitis. It consists of four components: stool frequency, rectal bleeding, physician's global assessment, and endoscopic findings. Total scores range from 0 to 12, with higher scores indicating more severe disease activity.
Simple Endoscopic Score for Crohn's Disease (SES-CD)
时间窗: Up to 10 years of follow-up
The Simple Endoscopic Score for Crohn's Disease (SES-CD) is an endoscopic index used to quantify mucosal disease activity in Crohn's disease. It assesses ulcer size, ulcerated surface, affected surface, and presence of strictures across bowel segments. Higher scores indicate more severe endoscopic disease activity.
PROMIS-10 Global Health Score
时间窗: Up to 10 years of follow-up
The PROMIS-10 Global Health is a validated patient-reported outcome measure assessing global physical and mental health. It consists of 10 items generating physical and mental health summary scores standardized to a T-score metric. Higher scores indicate better self-reported health status.
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
时间窗: Up to 10 years of follow-up
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a validated patient-reported outcome measure assessing health-related quality of life in patients with inflammatory bowel disease. It consists of 10 items covering bowel, systemic, emotional, and social domains. Total scores range from 10 to 70, with higher scores indicating better quality of life.
Bowel Urgency Score
时间窗: Up to 10 years of follow-up
The Bowel Urgency Score is a patient-reported measure assessing the severity and frequency of urgency to defecate. The range is from 0-10. Higher scores indicate greater bowel urgency and symptom burden.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
时间窗: Up to 10 years of follow-up
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a validated patient-reported outcome measure assessing fatigue and its impact on daily functioning in patients with chronic illness. It consists of 13 items, with total scores ranging from 0 to 52. Higher scores indicate less fatigue and better functional status.
次要结局
- Change in Disease activity over time(Up to 10 years of follow-up)
- Incidence of adverse events and serious adverse events(Up to 10 years of follow-up)
- Treatment persistence (drug persistence)(Up to 10 years of follow-up)
