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Active, Not Recruiting

NCT Number: NCT05774080

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health/Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. To characterize the natural history of disease in patients with GI disease from various etiologies

    Time frame: 20 Years

  2. To assess safety and effectiveness of treatments

    Time frame: 20 Years

Secondary outcomes

  1. To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD

    Time frame: 20 Years

  2. To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD

    Time frame: 20 Years

  3. To select and evaluate quality of care measures for patients with GI Diseases

    Time frame: 20 Years

Sponsors and collaborators

Lead sponsor

Target PharmaSolutions, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2037
Study completion
2037
First posted
Mar 17, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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