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Trial record 1 of 1 for:    NCT02834429
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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
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.


Condition or disease
Celiac Disease

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Study Type : Observational
Actual Enrollment : 1596 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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



Primary Outcome Measures :
  1. Positive and negative predictive values of the whole blood transglutaminase-based rapid test tissue for diagnosing coeliac disease [ Time Frame: 8 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Endoscopy patients at the Royal Hallamshire Hospital Sheffield
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
Department of Gastroenterology
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Study Director: David Sanders Sheffield Teaching Hospitals NHS FT
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02834429    
Other Study ID Numbers: STH15416
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases