The Prevalence of Serum Thyroid Hormone Autoantibodies in... | NCT04075851

Studies
The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases

NCT04075851

Sponsor

Shandong Provincial Hospital

Status

Unknown status

Last Update Posted

Apr 14, 2021Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Autoimmune Thyroid Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Aug 1, 2022Estimated

First Submitted Date

Aug 29, 2019

First Submission Date that Met QC Criteria

Aug 29, 2019

First Posted Date

Sep 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2021

Last Update Posted Date

Apr 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of thyroid hormone autoantibodies in AITD	Radioimmuno precipitation test used for thyroid hormone autoantibodies	measured after 1 year of follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Autoimmune thyroid diseases in endocrine outpatient department of shandong provincial hospital from August 1, 2019 to August 1, 2022

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ling Gao	Contact	+86 53168776910		gaoling1@medmall.com.cn

Overall Officials

Name	Affiliation	Role
Haiqing Zhang	shandong province hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shandong Province Hospital	Recruiting	Jinan	Shandong	250021	China

Condition Browse Module

MeSH Terms

ID	Term
D050031	Hashimoto Disease

Ancestor Terms

ID	Term
D013967	Thyroiditis, Autoimmune
D013966	Thyroiditis
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided