An Observational Study of Patients with Chronic Gastrointestinal Disease

Active, not recruiting

• Conditions: Gastrointestinal Diseases
• Interventions: Other: Observational

• Registration Number: NCT05774080
• Lead Sponsor: Target PharmaSolutions, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-17
• Study Start: 2023-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2037-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Engaged Cohort	Observational	Observational
Disease Cohort	Observational	Observational

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Atrium Health/Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States