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Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175760
First received: September 13, 2005
Last updated: April 11, 2011
Last verified: April 2011

September 13, 2005
April 11, 2011
December 2004
October 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00175760 on ClinicalTrials.gov Archive Site
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Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?
Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.

This study is to see if a high response to the TTG screening test for celiac disease is as accurate as the current method of diagnosing celiac disease which entails a general anesthetic and upper endoscopy to obtain biopsies of the small intestine. If the screening blood test is highly accurate, then some patients that are being evaluated for celiac disease may not require an upper GI endoscopy and can be treated more quickly. If they respond to the therapy then they will be deemed to have celiac disease.

All patients scheduled for upper GI endoscopy will be approached for recruitment into the study. A minimum of 4 small intestinal biopsies will be taken from all subjects and controls. All TTG specimens will be run through the hospital laboratory. Intermediate level TTG values 20-100 will be assessed separately and as part of the larger group. An optional part B of the study will assess the frequency of lactose intolerance in subjects prior to the start of a gluten free diet.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Aged 2 months to 18 years with a planned upper GI endoscopy.

Celiac Disease
Procedure: Diagnosis of Celiac Disease
During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion-All patients planned to undergo upper GI endoscopy with biopsies.

Exclusion Criteria:

Exclusion-refusal to participate, not planning to have biopsies performed with the endoscopy.

Both
2 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00175760
C04-0304
No
Dr. Collin Barker, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Dr. Collin Barker University of British Columbia
University of British Columbia
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP