Clinical Relevance of Typing HLA-DR7-DQ2 (HLA)

March 14, 2013 updated by: Juan Francisco Delgado de la Poza, Corporacion Parc Tauli
Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical and clinical behaviour as patients with HLA-DR3-DQ2 haplotype.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria i Universitaria Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Celiac disease patients who have been diagnosed in a Hospital by a Pediatrician.

Description

Inclusion Criteria:

  • Diagnosis of celiac disease following ESPGHAN recommendations
  • HLA-DQ2 typing including HLA-DR3-DQ2 and HLA-DR7-DQ2 haplotypes

Exclusion Criteria:

  • Patients who have not been diagnosed for celiac disease
  • HLA-DQ2 typing that not include HLA-DR7-DQ2 haplotype

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HLA-DR3-DQ2 patients
Patients with HLA-DR3-DQ2 haplotype
Other: There is not any intervention
HLA-DR7-DQ2 patients
Patients with HLA-DR7-DQ2 haplotype
Other: There is not any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-tissue transglutaminase
Time Frame: Up to 1 month after diagnosis
Up to 1 month after diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-Endomysium autoantibodies
Time Frame: Up to 1 month after diagnosis
Up to 1 month after diagnosis

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oberhuber histological damage classification
Time Frame: Up to 1 month after diagnosis
Up to 1 month after diagnosis
Clinical characteristics of celiac disease
Time Frame: Up to 1 month after diagnosis
Asymptomatic, intestinal symptoms, extra-intestinal symptoms, European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) score
Up to 1 month after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Juan Francisco Delgado de la Poza, Immunology Section, Laboratori. UDIAT-CD. Corporació Sanitària i Universitària Parc Taulí

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (ESTIMATE)

March 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Celiac disease and HLA-DQ2.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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