Predictors of Prognosis in IBD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic biopsy.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Predictors of Response After Induction Therapy With TNF-alpha Inhibitor in Inflammatory Bowel Disease, Comparison to Normal
Overview
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.
Interventions
- 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.
Primary outcome measures
- The expression level of multiple markers associated with IBD activity or prognosis [Time frame: baseline (at the time of enrollment)]
Secondary outcome measures (1)
- The change of expression level of multiple markers associated with IBD activity or prognosis [Time frame: Every 2 years. The examination will be suspended when treatment was ended.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Publications
- 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
Identifiers
NCT: NCT05653011 · B-1305-201-001