Predictors of Prognosis in IBD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-11

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

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

Endoscopic biopsy

Intervention Type 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.

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.

Endoscopic biopsy

Intervention Type 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.

TNF-alpha Inhibitor-treated IBD group

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

Endoscopic biopsy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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