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The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04075851
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Information provided by (Responsible Party):
Hai-qing Zhang, Shandong Provincial Hospital

Brief 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.

Condition or disease
Autoimmune Thyroid Disease

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Hashimoto or Grave's disease patients in treatment
Draw 10 ml venous blood
Hashimoto or Grave's disease patients on initial treatment
10 ml of venous blood was extracted every month for three months
Pregnant woman with Hashimoto or Grave's disease
10 ml venous blood was extracted every month to postpartum for 6 months
Healthy crowd
Draw 10 ml venous blood

Primary Outcome Measures :
  1. prevalence of thyroid hormone autoantibodies in AITD [ Time Frame: measured after 1 year of follow-up ]
    Radioimmuno precipitation test used for thyroid hormone autoantibodies

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Autoimmune thyroid diseases in endocrine outpatient department of shandong provincial hospital from August 1, 2019 to August 1, 2022

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

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 identifier (NCT number): NCT04075851

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Contact: Ling Gao +86 53168776910

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China, Shandong
Shandong Province Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Haiqing Zhang    86-53-68776094   
Sponsors and Collaborators
Shandong Provincial Hospital
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Study Chair: Haiqing Zhang shandong province hospital
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Responsible Party: Hai-qing Zhang, Professor, Shandong Provincial Hospital Identifier: NCT04075851    
Other Study ID Numbers: 20190801
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hai-qing Zhang, Shandong Provincial Hospital:
Autoimmune thyroid disease
Thyroid hormone autoantibodies
Hashimoto's thyroiditis
Grave's disease
Additional relevant MeSH terms:
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Thyroid Diseases
Hashimoto Disease
Endocrine System Diseases
Thyroiditis, Autoimmune