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Pre-endoscopy Serological Testing for Coeliac Disease; a Novel Approach Using Rapid Antibody Testing

NCT02834429 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1596

Last updated 2017-11-24

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • David Sanders · Sheffield Teaching Hospitals NHS FT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2017-08-31
Completion
2017-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02834429 on ClinicalTrials.gov