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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01931293
First received: June 10, 2013
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Atrophic Glossitis, Burning Mouth Syndrome
Dietary Supplement: Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Number of participants with finding the HLA-DRB1 and HLA-DQB1 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with finding the HLA-DRB1-DQB1 haplotype [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Number of participants with finding the presence of serum GPCA, TGA and TMA [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: April 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931293

Contacts
Contact: Andy Sun +8862-23123456 ext 67723 andysun7702@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Test2, Taiwan, test3
Contact: Andy Sun, Professor    +886-2-23123456 ext 67702    andysun7702@yahoo.com.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Andy Sun, Professor No Organizatioinal Affiliation
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01931293     History of Changes
Other Study ID Numbers: 201212066RIND
Study First Received: June 10, 2013
Last Updated: April 16, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
atrophic glossitis, burning mouth syndrome, gastric parietal cell antibody, thyroglobulin antibody, thyroid microsomal antibody, HLA-DR, HLA-DQ

Additional relevant MeSH terms:
Glossitis
Burning Mouth Syndrome
Burns
Atrophy
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries
Tongue Diseases
Pathological Conditions, Anatomical
Autoantibodies
Folic Acid
Vitamin B Complex
Vitamins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014