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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04075851
Other study ID # 20190801
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
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Completed NCT02061111 - NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease