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An Observational Study of Patients With Chronic Gastrointestinal Disease

T

Target PharmaSolutions

Status

Active, not recruiting

Conditions

Gastrointestinal Diseases

Treatments

Other: Observational

Study type

Observational

Funder types

Industry

Identifiers

NCT05774080
TARGET-GASTRO

Details and patient eligibility

About

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).

Enrollment

500,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

500,000 participants in 2 patient groups

Disease Cohort
Description:
Observational
Treatment:
Other: Observational
Engaged Cohort
Description:
Observational
Treatment:
Other: Observational

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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