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

NCT02834429 | Completed

• 1 other identifier: STH15416
• Study Type: observational
• Target: 1,596
• Locations: 1 country
• Sites: 1

Brief 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

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Positive and negative predictive values of the whole blood transglutaminase-based rapid test tissue for diagnosing coeliac disease

  8 years

Study Arms (1)

endoscopy patients

We will recruit patients (n=1000) from the endoscopy department at the Royal Hallamshire Hospital, Sheffield, United Kingdom (UK).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Endoscopy patients at the Royal Hallamshire Hospital Sheffield

You may qualify if:

• Patients aged 18 years or more undergoing clinically indicated gastroscopy with biopsy and coeliac serology testing

You may not qualify if:

• Patients with coagulopathy (INR \> 1.3 Platelets \< 80)
• Active gastrointestinal bleeding identified at endoscopy
• suspected carcinoma identified at gastroscopy

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Department of Gastroenterology

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Sanders

  Sheffield Teaching Hospitals NHS FT

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 15, 2016
• Study Start: February 1, 2010
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)