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NCT05774080 Clinical Trial

An Observational Study of Patients With Chronic Gastrointestinal Disease

Gastrointestinal Diseases Clinical Trial

Official title:
An Observational Study of Patients With Chronic Gastrointestinal Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05774080
Other study ID # TARGET-GASTRO
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2023
Est. completion date December 2037

Study information
Verified date March 2023
Source Target PharmaSolutions, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500000
Est. completion date December 2037
Est. primary completion date December 2037
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Observational
Observational

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Target PharmaSolutions, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary To characterize the natural history of disease in patients with GI disease from various etiologies 20 Years
Primary To assess safety and effectiveness of treatments 20 Years
Secondary To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD 20 Years
Secondary To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD 20 Years
Secondary To select and evaluate quality of care measures for patients with GI Diseases 20 Years
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