An Observational Study of Patients With Chronic Gastrointestinal Disease

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 Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Estimated): 500000

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health/Wake Forest University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Disease Cohort; Observational	Other: Observational; Observational
Engaged Cohort; Observational	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Target PharmaSolutions, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2037

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: TARGET-GASTRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No