An Observational Study of Patients With Chronic Gastrointestinal Disease
1 other identifier
observational
500,000
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 17, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2037
January 29, 2026
January 1, 2026
14.3 years
March 7, 2023
January 27, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
To characterize the natural history of disease in patients with GI disease from various etiologies
20 Years
To assess safety and effectiveness of treatments
20 Years
Secondary Outcomes (3)
To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD
20 Years
To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD
20 Years
To select and evaluate quality of care measures for patients with GI Diseases
20 Years
Study Arms (2)
Disease Cohort
Observational
Engaged Cohort
Observational
Interventions
Eligibility Criteria
The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.
You may qualify if:
- 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
You may not qualify if:
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter \> 3 years.
- Engaged Cohort
- Adult\* patients diagnosed and managed for these conditions invited to participate
- Ability to provide written informed consent
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atrium Health/Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Biospecimen
Whole blood serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 17, 2023
Study Start
August 1, 2023
Primary Completion (Estimated)
December 1, 2037
Study Completion (Estimated)
December 1, 2037
Last Updated
January 29, 2026
Record last verified: 2026-01