DEMETER
Research type
Research Study
Full title
Defining advanced endoscopic and molecular markers of mucosal healing after targeted therapies in Ulcerative Colitis
IRAS ID
303196
Contact name
Uday Shivaji
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The primary aim of treatment in ulcerative colitis is to achieve mucosal remission. At the moment, endoscopy is the gold standard for mucosal assessment, but in recent years growing evidence has shown how deeper mucosal healing, such as absence of inflammation also at histological level, correlates with better clinical outcome.
New advanced endoscopic technologies such as virtual chromoendoscopy and endocytoscopy have improved our abilities to detect subtle alterations of the mucosa and therefore could be used to guide more precise treatment. In particular, endocytoscopy, using ultra-high magnification, can provide real time microscopic imaging in vivo revealing architectural changes not visible on normal endoscopy.
In addition, because mucosal healing is not just the absence of inflammation but rather an active process of repair at cellular level it carries a distinctive molecular signature. Through RNA transcriptomics it is possible to quantify and characterise the gene expression specific of mucosal healing.
In this study we plan to assess changes in the mucosa of UC patients, before and after treatment with one of four biologic treatments routinely used in the treatment of UC (TNF inhibitors, Vedolizumab, Ustekinumab and Tofacitinib). Changes will be assessed using regular white light endoscopy, virtual chromoendoscopy and ultra-high magnification endocytoscopy (ECS). These advanced techniques are in use at leading endoscopy departments in UK, and already used in routine care.
We will also study the expression of molecular markers through RNA-transcriptomics of mucosal cells.
The follow-up of these patients will shed light on stability of mucosal healing, changes in mucosal macro and microscopic architecture, cellular molecular expression before and after therapy, and differences in these aspects depending on type treatment. Overall we will gain a better understanding of the concept of ‘deep remission’ in relation to therapies with biologicals or JAK inhibitors.REC name
London - London Bridge Research Ethics Committee
REC reference
22/PR/0409
Date of REC Opinion
13 Apr 2022
REC opinion
Favourable Opinion