An Observational Study of Patients With Chronic Gastroint... | NCT05774080

Studies
An Observational Study of Patients With Chronic Gastrointestinal Disease

NCT05774080

Sponsor

Target PharmaSolutions, Inc.

Status

Active, not recruiting

Last Update Posted

Jan 29, 2026Actual

Enrollment

500,000Estimated

Phase

Not provided

Conditions

Gastrointestinal Diseases

Interventions

Observational

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

Dec 2037Estimated

Completion Date

Dec 2037Estimated

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Jan 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Disease Cohort		Observational	Other: Observational
Engaged Cohort		Observational	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Observational	Disease Cohort Engaged Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To characterize the natural history of disease in patients with GI disease from various etiologies		20 Years
To assess safety and effectiveness of treatments		20 Years

Secondary Outcomes

Measure	Description	Time Frame
To evaluate provider management practices in the treatment of patients with EGIDs, UC and CD		20 Years
To evaluate longitudinal and patient reported outcomes in patients with EGIDs, UC and CD		20 Years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study will include adults who are being managed for the chronic GI diseases EGIDs, UC or CD.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atrium Health/Wake Forest University School of Medicine		Winston-Salem	North Carolina	27157	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005767	Gastrointestinal Diseases

ID	Term
D004066	Digestive System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided