Gastrointestinal DiseasesNCT05774080
An Observational Study of Patients With Chronic Gastrointestinal Disease
An observational study of Gastrointestinal Diseases, run by Target PharmaSolutions, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Observational
- How many people
- 500,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health/Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
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).
- Conditions
- Gastrointestinal Diseases
- Being tested
- Observational
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Disease Cohort | Observational Receives: Other: Observational | |
| Engaged Cohort | Observational Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the natural history of disease in patients with GI disease from various etiologies
Measured: 20 Years
To assess safety and effectiveness of treatments
Measured: 20 Years
Secondary outcomes (3)
To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD
Measured: 20 Years
To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD
Measured: 20 Years
To select and evaluate quality of care measures for patients with GI Diseases
Measured: 20 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Aug 2023
- Primary completionDec 2037 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Target PharmaSolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774080
- Sponsor's protocol ID
- TARGET-GASTRO
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Chronic Gastrointestinal Disease
- ClinicalTrials.gov ID
- NCT05774080
- Acronym / sponsor ID
- TARGET-GASTRO
- Conditions
- Gastrointestinal Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Target PharmaSolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Dec 2037 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Cohort | – | Other: ObservationalObservational |
| Engaged Cohort | – | Other: ObservationalObservational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Death
- Manual removal (sponsor or site request)
- No EHR interface encounter > 3 years.
- Engaged Cohort
- Patient expressed desire to withdraw consent to complete PROs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Disease Cohort, Engaged Cohort |
Primary outcome
To characterize the natural history of disease in patients with GI disease from various etiologies
Time frame: 20 Years
To assess safety and effectiveness of treatments
Time frame: 20 Years
3 secondary outcomes
To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD
Time frame: 20 Years
To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD
Time frame: 20 Years
To select and evaluate quality of care measures for patients with GI Diseases
Time frame: 20 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases, run by Target PharmaSolutions, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the natural history of disease in patients with GI disease from various etiologies (time frame: 20 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.