- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05774080
An Observational Study of Patients With Chronic Gastrointestinal Disease
March 19, 2023 updated by: Target PharmaSolutions, Inc.
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
500000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Disease Cohort
Observational
|
Observational
|
Engaged Cohort
Observational
|
Observational
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To characterize the natural history of disease in patients with GI disease from various etiologies
Time Frame: 20 Years
|
20 Years
|
To assess safety and effectiveness of treatments
Time Frame: 20 Years
|
20 Years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD
Time Frame: 20 Years
|
20 Years
|
To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD
Time Frame: 20 Years
|
20 Years
|
To select and evaluate quality of care measures for patients with GI Diseases
Time Frame: 20 Years
|
20 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2023
Primary Completion (Anticipated)
December 1, 2037
Study Completion (Anticipated)
December 1, 2037
Study Registration Dates
First Submitted
March 7, 2023
First Submitted That Met QC Criteria
March 7, 2023
First Posted (Actual)
March 17, 2023
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 19, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TARGET-GASTRO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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