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The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

Sponsor
Shandong Provincial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04075851
Collaborator
(none)
600
Enrollment
1
Location
36
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Aug 1, 2019
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Aug 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of thyroid hormone autoantibodies in AITD [measured after 1 year of follow-up]

      Radioimmuno precipitation test used for thyroid hormone autoantibodies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shandong Province Hospital Jinan Shandong China 250021

    Sponsors and Collaborators

    • Shandong Provincial Hospital

    Investigators

    • Study Chair: Haiqing Zhang, shandong province hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hai-qing Zhang, Professor, Shandong Provincial Hospital
    ClinicalTrials.gov Identifier:
    NCT04075851
    Other Study ID Numbers:
    • 20190801
    First Posted:
    Sep 3, 2019
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hai-qing Zhang, Professor, Shandong Provincial Hospital
    Autoimmune thyroid disease
    Thyroid hormone autoantibodies
    Hashimoto's thyroiditis
    Grave's disease
    Additional relevant MeSH terms:
    Thyroid Diseases
    Hashimoto Disease

    Study Results

    No Results Posted as of Apr 14, 2021