An Observational Study of Patients With Chronic Gastrointestinal Disease

• Sponsor: Target PharmaSolutions, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05774080
• Collaborator: (none)
• Enrollment: 500,000
• Anticipated Duration (Months): 175

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Diseases	Other: Observational

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: An Observational Study of Patients With Chronic Gastrointestinal Disease
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2037
• Anticipated Study Completion Date: Dec 1, 2037

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To characterize the natural history of disease in patients with GI disease from various etiologies [20 Years]

2. To assess safety and effectiveness of treatments [20 Years]

Secondary Outcome Measures

1. To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD [20 Years]

2. To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD [20 Years]

3. To select and evaluate quality of care measures for patients with GI Diseases [20 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Target PharmaSolutions, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Target PharmaSolutions, Inc.
• ClinicalTrials.gov Identifier: NCT05774080
• Other Study ID Numbers: TARGET-GASTRO
• First Posted: Mar 17, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Diseases; Digestive System Diseases

Study Results

No Results Posted as of Mar 22, 2023