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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