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Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited (DGP-CeliacDis)

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ClinicalTrials.gov Identifier: NCT03320811
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date October 23, 2017
First Posted Date October 25, 2017
Last Update Posted Date October 25, 2017
Actual Study Start Date January 1, 2015
Actual Primary Completion Date September 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 23, 2017)
celiac disease [ Time Frame: Day 0 ]
The celiac disease diagnosis was based on the histological lesions at duodenal biopsies (villous atrophy). Biopsy samples were obtained during upper gastrointestinal tract endoscopy.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited
Official Title Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited
Brief Summary

Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small bowel mucosa, triggered by the ingestion of gluten-containing grains.

The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper endoscopy. Since 1990, the availability of serological tests has contributed to a different perception of the disease. Serological testing is now considered fundamental for celiac disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and anti-reticulin antibodies. Recently, several studies showed that deamidated products of gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced into the wide spectrum of serological tests for celiac disease.

Detailed Description The aim was to assess the clinical relevance of anti-deamidated gliadin peptide antibodies compared with the other common celiac markers.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed.
Condition Celiac Disease
Intervention Other: Data record
Study Groups/Cohorts
  • group "celiac disease"
    Intervention: Other: Data record
  • group "no celiac disease"
    Intervention: Other: Data record
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
Actual Enrollment
 (submitted: October 23, 2017)
2026
Original Actual Enrollment Same as current
Actual Study Completion Date January 1, 2016
Actual Primary Completion Date September 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed between 1 april 2012 to 31 december 2014

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03320811
Other Study ID Numbers 2016Ao005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CHU de Reims
Study Sponsor CHU de Reims
Collaborators Not Provided
Investigators Not Provided
PRS Account CHU de Reims
Verification Date October 2017