NCT03320811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,026

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

October 23, 2017

Last Update Submit

October 23, 2017

Conditions

Keywords

Celiac diseaseserological testsanti-deamidated gliadin peptide antibodies

Outcome Measures

Primary Outcomes (1)

  • celiac disease

    The celiac disease diagnosis was based on the histological lesions at duodenal biopsies (villous atrophy). Biopsy samples were obtained during upper gastrointestinal tract endoscopy.

    Day 0

Study Arms (2)

group "celiac disease"

Other: Data record

group "no celiac disease"

Other: Data record

Interventions

group "celiac disease"group "no celiac disease"

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 25, 2017

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

January 1, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations