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

• ClinicalTrials.gov Identifier: NCT03320811
• Recruitment Status: Completed
• First Posted: October 25, 2017
• Last Update Posted: October 25, 2017
• Sponsor: CHU de Reims
• 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

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

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