Autoimmune Thyroid Disease Genetic Study
This study has been completed.
Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00958113
First received: August 11, 2009
Last updated: May 26, 2015
Last verified: May 2015
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Purpose
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 |
|---|
|
Hashimoto's Disease Graves' Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Autoimmune Thyroid Disease Genetic Study |
Resource links provided by NLM:
MedlinePlus related topics:
Thyroid Diseases
Drug Information available for:
Thyroid
U.S. FDA Resources
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Map and identify genes that confer susceptibility to Autoimmune Thyroid Disease (AITD) [ Time Frame: Approximately one year after all samples are collected ] [ Designated as safety issue: No ]SNP genotypes (allele frequencies, genotype frequencies) will be compared in cases versus controls.
Biospecimen Retention: Samples With DNA
Saliva
| Enrollment: | 199 |
| Study Start Date: | July 2009 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 7 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
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: NCT00958113
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00958113 History of Changes |
| Other Study ID Numbers: | 08-0931 |
| Study First Received: | August 11, 2009 |
| Last Updated: | May 26, 2015 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 29, 2016