Pre-endoscopy Serological Testing for Coeliac Disease; a Novel Approach Using Rapid Antibody Testing
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|ClinicalTrials.gov Identifier: NCT02834429|
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : November 24, 2017
The aim of this study is to assess the clinical utility of the whole blood transglutaminase-based rapid test against current serological tests and the gold standard of duodenal biopsy. The investigators will recruit patients (n=1000) from the endoscopy department at the Royal Hallamshire Hospital, Sheffield, United Kingdom (UK). The patients recruited for this study will already have been referred for a consultation and gastroscopy. In addition, these patients will already have been serologically tested for IgA TTG, EMA and a total IgA immunoglobulin level (as per normal clinical practice).
All duodenal biopsy specimens will be fixed in buffered formalin and embedded in paraffin wax. Standard, 3μm thick sections at three levels will be stained with haematoxylin and eosin and reported routinely. Additionally, biopsies demonstrating increased intraepithelial lymphocytes only (changes compatible with but not diagnostic of coeliac disease) will be stained with KiRAS or CD4/CD8 which are markers for coeliac disease.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1596 participants|
|Official Title:||Pre-endoscopy Serological Testing for Coeliac Disease - a Novel Approach Using Rapid Antibody Testing.|
|Actual Study Start Date :||February 2010|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||October 2017|
We will recruit patients (n=1000) from the endoscopy department at the Royal Hallamshire Hospital, Sheffield, United Kingdom (UK).
- Positive and negative predictive values of the whole blood transglutaminase-based rapid test tissue for diagnosing coeliac disease [ Time Frame: 8 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834429
|Department of Gastroenterology|
|Sheffield, South Yorkshire, United Kingdom, S10 2JF|
|Study Director:||David Sanders||Sheffield Teaching Hospitals NHS FT|