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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00175760
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
University of British Columbia

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 15, 2005
Last Update Posted Date April 12, 2011
Study Start Date December 2004
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease?
Official Title Prospective Assessment of High Titre TTG to Diagnose Celiac Disease in Select Paediatric Patients.
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Aged 2 months to 18 years with a planned upper GI endoscopy.
Condition Celiac Disease
Intervention Procedure: Diagnosis of Celiac Disease
During GI endoscopy a minimum of 4 small intestinal biopsies will be taken from all subjects and controls.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September¬†13,¬†2005)
100
Original Enrollment Same as current
Actual Study Completion Date October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00175760
Other Study ID Numbers C04-0304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Collin Barker, University of British Columbia
Study Sponsor University of British Columbia
Collaborators Not Provided
Investigators
Principal Investigator: Dr. Collin Barker University of British Columbia
PRS Account University of British Columbia
Verification Date April 2011