Predictors of Prognosis in IBD Patients

NCT05653011 | Recruiting

• 1 other identifier: B-1305-201-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Keywords

inflammatory bowel disease; ulcerative colitis; crohn's disease

Outcome Measures

Primary Outcomes (1)

• The expression level of multiple markers associated with IBD activity or prognosis

  The expression level of multiple markers was evaluated through RT-qPCR using endoscopically biopsied samples or blood samples. Markers include TGF-b, SLUG, SNAIL, E-cadherin, vimentin, OLFM4, LGR5, a-SMA, FSP1, IL-17A, IL-23, TGF-b, IL-6, IFN-r, IL-1b, FOXP3, PD-1, CD68, PAD4, COL3A1, TIMP3, LOX, ACTA2, ITGB6, CAV-1 etc.

  baseline (at the time of enrollment)

Secondary Outcomes (1)

• The change of expression level of multiple markers associated with IBD activity or prognosis

  Every 2 years. The examination will be suspended when treatment was ended.

Study Arms (3)

Control group

Patients who are not diagnosed with inflammatory bowel disease and have colitis.

Other: Endoscopic biopsy

TNF-alpha Inhibitor-naive IBD group

Patients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment.

Other: Endoscopic biopsy

TNF-alpha Inhibitor-treated IBD group

Patients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment.

Other: Endoscopic biopsy

Interventions

Endoscopic biopsy OTHER

When patients have colonoscopy or sigmoidoscopy for evaluation of their disease course, biopsied samples are collected. In the IBD group, samples are obtained at endoscopically active and/or inactive lesions. In the control group, samples are obtained at endoscopically normal lesions.

Control group; TNF-alpha Inhibitor-naive IBD group; TNF-alpha Inhibitor-treated IBD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visited Seoul National University Bundang Hospital.

You may qualify if:

• control group: Patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma)
• TNF-α inhibitor-naive IBD group: IBD patients who do not have a history of TNF-α inhibitor treatment
• TNF-α inhibitor-treated IBD group: IBD patients who are treated with TNF-α inhibitor

You may not qualify if:

• Age under 18 years
• Patients who were treated with antibiotics or probiotics within the last 3 months

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

• Jun YK, Kim N, Yoon H, Park JH, Kim HK, Choi Y, Lee JA, Shin CM, Park YS, Lee DH. Molecular Activity of Inflammation and Epithelial-Mesenchymal Transition in the Microenvironment of Ulcerative Colitis. Gut Liver. 2024 Nov 15;18(6):1037-1047. doi: 10.5009/gnl230283. Epub 2024 Feb 22.

  PMID: 38384179 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

endoscopically biopsied sample blood sample

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Nayoung Kim, M.D., Ph.D

  Seoul National University Bundang Hospital

  STUDY CHAIR

Central Study Contacts

Yu kyung Jun, M.D., Ph.D

CONTACT

+ 82-31-787-7845; juk0220@nate.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: December 15, 2022
• Study Start: March 11, 2013
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)