NCT07166588

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2021Dec 2028

Study Start

First participant enrolled

January 20, 2021

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5.9 years

First QC Date

September 3, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Ulcerative ColitisInflammatory Bowel DiseaseCrohn Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

feces, blood, tissue, RNA

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
72 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

January 20, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations