Autoimmune Thyroid Disease Genetic Study

Graves' Disease Clinical Trial

Official title:

Autoimmune Thyroid Disease Genetic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958113
• Other study ID #: 08-0931
• Status: Completed
• Phase: N/A
• First received: August 11, 2009
• Last updated: May 26, 2015
• Start date: July 2009
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: May 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease
• Hashimoto Disease
• Hashimoto's Disease
• Thyroid Diseases

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Map and identify genes that confer susceptibility to Autoimmune Thyroid Disease (AITD)	SNP genotypes (allele frequencies, genotype frequencies) will be compared in cases versus controls.	Approximately one year after all samples are collected	No