Evidence map›Paper›PMID 25041724›Full record

ArticleAlimentary pharmacology & therapeutics2014

Validated gene expression biomarker analysis for biopsy-based clinical trials in ulcerative colitis.

B S Boland, D L Boyle, W J Sandborn, G S Firestein, B G Levesque, J Hillman, B Zhang, J Proudfoot, L Eckmann, P B Ernst and 4 more

Abstract read
In one paragraph

Article in Alimentary pharmacology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

B S BolandDivision 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.
D L Boyle
W J Sandborn
G S Firestein
B G Levesque
J Hillman
B Zhang
J Proudfoot
L Eckmann
P B Ernst
J Rivera-Nieves
S Pola
N Copur-Dahi
J T Chang

Funding

San Diego Clinical and Translational Research InstituteUL1TR000100 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S · 2012 to 2015
$19.7M
Training Grant in GastroenterologyT32DK007202 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GHOSH, PRADIPTA · 1985 to 2022
$7.7M
The Role of the Adenosine Receptor in Th Cell Development and FunctionR01AI079145 · NIAID · UNIVERSITY OF VIRGINIA · PI ERNST, PETER B. · 2010 to 2022
$4.7M
The UCSD Digestive Diseases Research Development CenterR24DK080506 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ECKMANN, LARS · 2008 to 2012
$2.7M
Understanding the Basis for Cellular Diversity During Adaptive ImmunityDP2OD008469 · OD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CHANG, JOHN T · 2011 to 2011
$2.3M
Role of atypical Protein Kinase C in Inflammatory Bowel DiseaseR01DK093507 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CHANG, JOHN T · 2012 to 2016
$1.7M
NCATS NIH HHS UL1 TR000100NCATS NIH HHS UL1TR000100NCRR NIH HHS 1TL1RR03197NIDDK NIH HHS DK080506NIDDK NIH HHS DK093507NIDDK NIH HHS R01 DK093507NIDDK NIH HHS R24 DK080506NIDDK NIH HHS T32 DK007202NIH HHS DP2 OD008469
6 · The paper itself

Abstract

backgroundAccurate and reproducible measurement of expression of pro-inflammatory cytokines in colonic biopsies from patients with ulcerative colitis (UC) is essential for proof-of-concept and mechanism-of-action studies. Few studies have rigorously established the number of biopsies required for accurate and reproducible biomarker measurements.

aimTo validate methods for measuring changes in gene expression in colonic biopsy samples.

methodsTwelve colonic biopsies were obtained from each of six healthy controls, six patients with inactive UC and seven patients with active UC. Mayo endoscopic scores were used as a clinical reference standard. Quantitative PCR was used to assess mRNA expression of eight known inflammatory genes. The power to detect a reduction in gene expression in active vs. inactive UC was calculated using a linear mixed effect model.

resultsmRNA analysis of colonic biopsies is a sensitive and feasible approach for measuring inflammatory gene expression in colonic biopsies. Inflammatory biomarkers correlate with Mayo endoscopic subscores for each colonic region. For most genes, three rectal biopsies from two to four patients are required to detect changes in gene expression corresponding to active vs. inactive UC to achieve a power of 80% with an alpha of 0.05.

conclusionOur data suggest that systematic measurement of inflammatory biomarkers at the mRNA level can be a valuable tool for hypothesis testing, and assessment of clinical activity and response to therapy in ulcerative colitis.

Indexed as

Gene Expression RegulationAdultAgedBiomarkersBiopsyClinical Trials as TopicColitis, UlcerativeColonCytokinesFemaleHumansMaleMiddle AgedRNA, MessengerBiomarkersCytokinesRNA, Messenger

Identifiers

PMID25041724
PMCPMC4143528

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.