HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome

January 28, 2016 updated by: National Taiwan University Hospital
Patients with atrophic glossitis (AG) or burning mouth syndrome (BMS) are frequently encountered in the oral mucosal disease clinic. Our previous studies found a significantly higher frequency (26.7%) of serum gastric parietal cell antibody (GPCA) and a significantly higher frequency (31%) of serum thyroglobulin antibody (TGA) or thyroid microsomal antibody (TMA) in AG patients than in healthy control subjects. Moreover, there is also a significantly higher frequency (13.3%) of serum GPCA or a significantly higher frequency (23.5%) of serum TGA or TMA in BMS patients than in healthy control subjects. Because patients with one organ-specific autoantibody are prone to have another organ-specific autoantibody in sera, we also evaluated whether AG or BMS patients with GPCA are prone to have TGA or TMA in sera and vice versa. We further found that 25.3% of TGA- or TMA-positive AG or BMS patients also have GPCA, 32.3% GPCA-positive AG or BMS patients also have TGA, and 30.6% GPCA-positive AG or BMS patients also have TMA in their sera. Without proper diagnosis and treatment, patients with GPCA are more likely to develop autoimmune atrophic gastritis and subsequently progress to gastric carcinoma, and patients with TGA or TMA may develop autoimmune thyroid disease and finally result in thyroid dysfunction. In addition, previous studies have shown a close association of the HLA-DR or HLA-DQ loci with the presence of autoantibodies (such as GPCA, TGA or TMA) in patients with different types of autoimmune disease. Therefore, in the following 3-year research project, we plan to collect 300 AG and 450 BMS patients from the oral mucosal disease clinic of Department of Dentistry, National Taiwan University Hospital. For each year, 100 AG and 150 BMS patients are collected. A 10-cc blood sample will be drawn from each patient, with 5 cc being used for the determination of the serum levels of GPCA, TGA and TMA and another 5 cc being used for the HLA-DRB1 and HLA-DQB1-genotyping using the polymerase chain reaction with sequence-specific primer (PCR-SSP) typing technique. At the end of this 3-year study, we will realize the frequencies of presence of GPCA, TGA and TMA in sera of our 300 AG or 450 BMS patients. After statistical analyses, we will also know which specific HLA-DRB1 or HLA-DQB1 allele and which specific DRB1-DQB1 haplotype are responsible for the possession of GPCA, TGA or TMA in sera of our AG or BMS patients. In addition, we will understand which specific HLA-DRB1 or HLA-DQB1 allele and which specific DRB1-DQB1 haplotype are responsible for the possession of GPCA in TGA- or TMA-positive AG or BMS patients as well as for the possession of TGA or TMA in GPCA-positive AG or BMS patients. With this important information in mind, we can predict the development of the specific autoimmune diseases such as autoimmune atrophic gastritis and autoimmune thyroid diseases and then adopt proper early diagnosis and treatment to prevent the future occurrence of these diseases and their potential complications (such as gastric carcinoma or thyroid dysfunction).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Test2
      • Taipei, Test2, Taiwan, test3
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of atrophic glossitis or burning mouth syndrome.
  • Patient's age is between 20 and 80 years.

Exclusion Criteria:

  • An expectant mother or patients without atrophic glossitis or burning mouth syndrome.
  • Patients have atrophic glossitis or burning mouth syndrome but refuse to take blood sample.
  • Betel guid chewers or heavy alcohol drinkers, patients with autoimmune disease, stroke, liver or kidney dysfunction, or cardiovascular disaeses.

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HLA-DR and DQ antigens
Isolation of patient's lymphocytes from 10 cc of blood to determine the HLA-DR and DQ antigens at the first visit.
Dietary supplement: Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic
Vitamin Supplement therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with finding the HLA-DRB1 and HLA-DQB1
Time Frame: 3 years
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with finding the HLA-DRB1-DQB1 haplotype
Time Frame: 3 years
3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with finding the presence of serum GPCA, TGA and TMA
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andy Sun, Professor, No Organizatioinal Affiliation

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201212066RIND

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