The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

Autoimmune Thyroid Disease Clinical Trial

Official title:

The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075851
• Other study ID #: 20190801
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: April 2021
• Source: Shandong Provincial Hospital
• Contact: Ling Gao
• Phone: +86 53168776910
• Email: gaoling1[@]medmall.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Thyroid hormone autoantibodies(THAA) in serum can Interfere radioimmunoassay for the determination of free thyroid hormones. Thyroid function test plays a key role in the diagnosis and treatment of autoimmune thyroid disease (AITD), and abnormal examination results in misdiagnosis and mistreatment. At present, the epidemiological results of THAA in AITD are inconsistent, and the pathogenesis has not been clarified. However, there is no relevant research on THAA in China. This project intends to collect AITD patients and healthy people, detecting THAA, at the same time testing thyroid function and thyroid autoantibodies, definiting positive rate of THAA in AITD patients, observing the effect of common therapeutic drugs for AITD on THAA, investigating the rule of THAA influencing thyroid function test results .This project will provide the basis and method for how to effectively avoid THAA interfering with thyroid function test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old

Exclusion Criteria:

• Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system

Related Conditions & MeSH terms

• Autoimmune Thyroid Disease
• Hashimoto Disease
• Thyroid Diseases

Locations

Country	Name	City	State
China	Shandong Province Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of thyroid hormone autoantibodies in AITD	Radioimmuno precipitation test used for thyroid hormone autoantibodies	measured after 1 year of follow-up