NCT05774080进行中（未招募）不适用
An Observational Study of Patients With Chronic Gastrointestinal Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500,000
- 试验地点
- 1
- 主要终点
- To characterize the natural history of disease in patients with GI disease from various etiologies
研究概览
简要总结
TARGET-GASTRO is an observational research study to conduct a comprehensive review of outcomes for patients with the chronic gastrointestinal (GI) diseases: eosinophilic gastrointestinal disease (EGID), ulcerative colitis (UC) or Crohn's disease (CD).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Disease Cohort
- •Inclusion Criteria:
- •Adult* patients at the time of enrollment with a diagnosis or major symptom of EGIDs, UC, or CD by ICD-10 code in the EHR interface
排除标准
- •Manual removal (sponsor or site request)
- •No EHR interface encounter > 3 years.
- •Engaged Cohort
- •Inclusion Criteria:
- •Adult* patients diagnosed and managed for these conditions invited to participate
- •Ability to provide written informed consent
- •Exclusion Criteria:
- •Patient expressed desire to withdraw consent to complete PROs
- •Failure to complete PROs within 24 weeks of initial invitation
- •Greater than 24 months lapse of survey completion after baseline surveys completed
- •Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort.
研究组 & 干预措施
Disease Cohort
Observational
干预措施: Observational (Other)
Engaged Cohort
Observational
干预措施: Observational (Other)
结局指标
主要结局
To characterize the natural history of disease in patients with GI disease from various etiologies
时间窗: 20 Years
To assess safety and effectiveness of treatments
时间窗: 20 Years
次要结局
- To select and evaluate quality of care measures for patients with GI Diseases(20 Years)
- To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD(20 Years)
- To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD(20 Years)
研究者
研究点 (1)
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