An Observational Study of Patients With Chronic Gastrointestinal Disease
Overview
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).
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Other
- Study Primary Completion Date: December 2037
Interventions
- Other: Observational
- Observational
Arms, Groups and Cohorts
- Disease Cohort
- Observational
- Engaged Cohort
- Observational
Clinical Trial Outcome Measures
Primary Measures
- To characterize the natural history of disease in patients with GI disease from various etiologies
- Time Frame: 20 Years
- To assess safety and effectiveness of treatments
- Time Frame: 20 Years
Secondary Measures
- To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD
- Time Frame: 20 Years
- To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD
- Time Frame: 20 Years
- To select and evaluate quality of care measures for patients with GI Diseases
- Time Frame: 20 Years
Participating in This Clinical Trial
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 Exclusion Criteria:
- Death – 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Target PharmaSolutions, Inc.
- Provider of Information About this Clinical Study
- Sponsor
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