Research for the Precision Medicine in the Treatment of I... | NCT07166588

Studies
Research for the Precision Medicine in the Treatment of Inflammatory Bowel Disease

NCT07166588

Sponsor

Seoul National University Hospital

Status

Enrolling by invitation

Last Update Posted

Sep 15, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Crohn Disease (CD)
Ulcerative Colitis (UC)
IBD (Inflammatory Bowel Disease)

Interventions

Not provided

Countries

South Korea

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Sep 3, 2025

First Submission Date that Met QC Criteria

Sep 3, 2025

First Posted Date

Sep 10, 2025Actual

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

Sep 9, 2025

Last Update Posted Date

Sep 15, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to establish an integrated cohort of patients with inflammatory bowel disease (IBD) from Seoul National University Hospital, Seoul National University Boramae Medical Center, and Seoul National University Bundang Hospital. Through this cohort, we seek to develop a prognostic prediction model for IBD patients and a predictive model for therapeutic responses to biologic agents and small molecule therapies.

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

Yes

Target Follow-Up Duration

72 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction model in the patients with inflammatory bowel disease for treatment response	Development of a prognostic prediction model for patients with inflammatory bowel disease and a predictive model for therapeutic response to biologic agents and small molecule therapies	From enrollment to the end of treatment at 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 10 years or older who have been newly diagnosed with inflammatory bowel disease or are under follow-up monitoring.

Exclusion Criteria:

Patients diagnosed with cancer or with a history of cancer treatment.
Participation may be restricted at the discretion of the medical team.
Infants and young children under the age of 10.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with inflammatory bowel disease, including Crohn's disease and ulcerative colitis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Seoul	03080	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided