Predictors of Prognosis in IBD Patients

Study Overview
=================
Brief Summary
-----------------
A study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

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.

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

Conditions
-----------------
Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Endoscopic biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Exclusion Criteria: Age under 18 years Patients who were treated with antibiotics or probiotics within the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Patients who are not diagnosed with inflammatory bowel disease and have colitis. | Other: Endoscopic biopsy<br>* 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.<br>|
| TNF-alpha Inhibitor-naive IBD group<br>Patients who are diagnosed with inflammatory bowel disease but do not have a history of TNF-a inhibitor treatment. | Other: Endoscopic biopsy<br>* 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.<br>|
| TNF-alpha Inhibitor-treated IBD group<br>Patients who are diagnosed with inflammatory bowel disease and have a history of TNF-a inhibitor treatment. | Other: Endoscopic biopsy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of expression level of multiple markers associated with IBD activity or prognosis | 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) | Every 2 years. The examination will be suspended when treatment was ended. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory bowel disease, ulcerative colitis, crohn's disease