An Observational Study of Patients with Chronic Gastrointestinal Disease

NCT ID: NCT05774080

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2037-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Gastrointestinal Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Disease Cohort

Observational

Observational

Intervention Type OTHER

Observational

Engaged Cohort

Observational

Observational

Intervention Type OTHER

Observational

Interventions

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Observational

Observational

Intervention Type OTHER

Eligibility Criteria

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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


* Adult\* patients diagnosed and managed for these conditions invited to participate
* Ability to provide written informed consent

Exclusion Criteria

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years.

Engaged Cohort


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Target PharmaSolutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atrium Health/Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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TARGET-GASTRO

Identifier Type: -

Identifier Source: org_study_id

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