Predictors of Prognosis in IBD Patients

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05653011

Collaborator

(none)

100

Enrollment

Location

129.7

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease	Other: Endoscopic biopsy

Detailed Description

Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory disease composed of two types: Crohn's disease (CD) and ulcerative colitis (UC). It is difficult to cure the IBD completely and patients with clinical or endoscopic remission can worsen again. Therefore, predicting the prognosis of patients with IBD is still challenging.

Endoscopic biopsied samples and blood samples from IBD patients and non-IBD controls have been collected and the expression levels of multiple markers which are associated with disease activity and severity will be assessed. The correlation between expression levels of multiple markers and prognosis will be evaluated.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal

Actual Study Start Date :

Mar 11, 2013

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Control group Patients who are not diagnosed with inflammatory bowel disease and have colitis.	Other: Endoscopic biopsy 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.
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 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.
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 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.

Arm

Intervention/Treatment

Control group

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

Other: Endoscopic biopsy

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.

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

Outcome Measures

Primary Outcome Measures

The expression level of multiple markers associated with IBD activity or prognosis [baseline (at the time of enrollment)]
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.

Secondary Outcome Measures

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.]
The change of 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. (compared to results 2 year ago)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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