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Published on: November 30, 2016
Validated gene expression biomarker analysis for biopsy-based clinical trials in ulcerative colitis
B S Boland1, D L Boyle, W J Sandborn
1Division of Gastroenterology, Department of Medicine, Inflammatory Bowel Disease Center, University of California San Diego, La Jolla, CA, USA; UCSD Digestive Diseases Research Development Center, University of California San Diego, La Jolla, CA, USA.
Measuring inflammatory gene expression in ulcerative colitis (UC) biopsies is crucial. Three rectal biopsies from a few patients can accurately detect gene expression changes in active versus inactive UC.
Area of Science:
- Gastroenterology
- Molecular Biology
- Clinical Research
Background:
- Accurate measurement of pro-inflammatory cytokines in ulcerative colitis (UC) colonic biopsies is vital for research.
- Few studies have determined the necessary number of biopsies for reliable biomarker quantification.
Purpose of the Study:
- To validate methods for measuring gene expression changes in colonic biopsy samples.
- To establish the optimal number of biopsies for detecting inflammatory gene expression differences in UC.
Main Methods:
- Quantitative PCR (qPCR) was used to analyze mRNA expression of eight inflammatory genes in colonic biopsies from healthy controls, inactive UC, and active UC patients.
- Mayo endoscopic scores served as a clinical reference standard.
- A linear mixed effect model calculated the statistical power to detect gene expression reductions in active versus inactive UC.
Main Results:
- mRNA analysis of colonic biopsies is a sensitive and feasible method for assessing inflammatory gene expression.
- Inflammatory biomarkers showed correlation with Mayo endoscopic subscores.
- Three rectal biopsies from 2-4 patients are sufficient to detect gene expression changes between active and inactive UC with 80% power.
Conclusions:
- Systematic mRNA measurement of inflammatory biomarkers in UC biopsies is valuable for hypothesis testing.
- This approach aids in assessing clinical activity and treatment response in ulcerative colitis.
- The findings provide a guideline for sample size in UC biomarker studies.
