The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 29, 2019
CompletedFirst Posted
Study publicly available on registry
September 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedApril 14, 2021
April 1, 2021
3 years
August 29, 2019
April 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
prevalence of thyroid hormone autoantibodies in AITD
Radioimmuno precipitation test used for thyroid hormone autoantibodies
measured after 1 year of follow-up
Study Arms (4)
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
Eligibility Criteria
Patients with Autoimmune thyroid diseases in endocrine outpatient department of shandong provincial hospital from August 1, 2019 to August 1, 2022
You may qualify if:
- male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old
You may not qualify if:
- Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Province Hospital
Jinan, Shandong, 250021, China
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Haiqing Zhang
shandong province hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 29, 2019
First Posted
September 3, 2019
Study Start
August 1, 2019
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
April 14, 2021
Record last verified: 2021-04