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Autoimmune Thyroid Disease Genetic Study

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ClinicalTrials.gov Identifier: NCT00958113
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The hypothesis of this project is that specific genes can be identified that contribute to genetic susceptibility to autoimmune thyroid disease (AITD) in different populations. The specific aim of this project is carry out one or more genomewide association studies (GWAS) to map and ultimately identify genes that confer susceptibility to AITD. AITD consists principally of Hashimoto's Thyroiditis (HT) and Graves' Disease (GD), characterized clinically generally by hypothyroidism and hyperthyroidism, respectively. Both HT and GD are autoimmune diseases characterized by infiltration of the thyroid by T and B cells that are reactive with thyroid antigens and by the production of thyroid autoantibodies (TAB). While there is some evidence that there may be genes specific to either GD or HT, other genes appear to be common to both, and some genes may furthermore be in common to susceptibility to other autoimmune diseases. Genes known to play a role in AITD include HLA, CTLA4, thyroglobulin (TG), THSR, and CD40, PTPN2, and PTPN22, several of which are also involved in susceptibility to other autoimmune diseases. All of these genes interact in a complex manner that has yet to be understood. Furthermore, it seems clear that relatively few of the genes involved in susceptibility to AITD have thus far been discovered.

Condition or disease
Hashimoto's Disease Graves' Disease

Study Design
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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Autoimmune Thyroid Disease Genetic Study
Study Start Date : July 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Autoimmune Thyroid Disease
Patients with Hashimoto's disease or Graves' disease
Unaffected Population
Population not known to be affected by Hashimoto's Disease or Graves' Disease


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Map and identify genes that confer susceptibility to Autoimmune Thyroid Disease (AITD) [ Time Frame: Approximately one year after all samples are collected ]
    SNP genotypes (allele frequencies, genotype frequencies) will be compared in cases versus controls.


Biospecimen Retention:   Samples With DNA
Saliva

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in Endocrinology Clinic
Criteria

Inclusion Criteria:

  • Clinical diagnosis of abnormal thyroid function (hypo or hyperthyroidism) due to autoimmune thyroid disease

Exclusion Criteria:

  • Lack of documentation of abnormal thyroid function or clear evidence of autoimmune etiology
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958113


Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Richard Spritz, MD University of Colorado, Denver
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00958113     History of Changes
Other Study ID Numbers: 08-0931
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Graves Disease
Thyroid Diseases
Hashimoto Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
 Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Thyroiditis, Autoimmune
Thyroiditis