An Observational Study of Patients With Chronic Gastrointestinal Disease

Target PharmaSolutions, Inc.1 个研究点分布在 1 个国家目标入组 500,000 人2023年8月1日

适应症Gastrointestinal Diseases

干预措施Observational

概览

阶段: 不适用
干预措施: Observational
疾病 / 适应症: Gastrointestinal Diseases
发起方: Target PharmaSolutions, Inc.
入组人数: 500000
试验地点: 1
主要终点: To characterize the natural history of disease in patients with GI disease from various etiologies
状态: 进行中（未招募）
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2023年8月1日

结束日期

2037年12月1日

最后更新

3个月前

研究类型

Observational

性别

All

研究者

发起方

Target PharmaSolutions, Inc.

责任方

Sponsor

入排标准

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

研究组 & 干预措施

Disease Cohort

Observational

干预措施: Observational

Engaged Cohort

Observational

干预措施: Observational

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)