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

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ClinicalTrials.gov Identifier: NCT01931293
Recruitment Status : Unknown
Verified January 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 29, 2013
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE June 10, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date February 1, 2016
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
Number of participants with finding the HLA-DRB1 and HLA-DQB1 [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Finding the HLA-DRB1 and HLA-DQB1 of the patients [ Time Frame: 2013/03/18-2016/03/17 ]
Change History Complete list of historical versions of study NCT01931293 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
Number of participants with finding the HLA-DRB1-DQB1 haplotype [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Finding the HLA-DRB1-DQB1 haplotype [ Time Frame: 2013/03/18-2016/03/17 ]
Current Other Pre-specified Outcome Measures
 (submitted: April 16, 2014)
Number of participants with finding the presence of serum GPCA, TGA and TMA [ Time Frame: 3 years ]
Original Other Pre-specified Outcome Measures
 (submitted: August 26, 2013)
Finding the presence of serum GPCA, TGA and TMA in patients [ Time Frame: 2013/03/18-2016/03/17 ]
 
Descriptive Information
Brief Title  ICMJE HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome
Official Title  ICMJE HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Atrophic Glossitis, Burning Mouth Syndrome
Intervention  ICMJE Dietary Supplement: Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic
Vitamin Supplement therapy
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 26, 2013)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01931293
Other Study ID Numbers  ICMJE 201212066RIND
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andy Sun, Professor No Organizatioinal Affiliation
PRS Account National Taiwan University Hospital
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP