The Relationship Between NK Cell and Graves' Disease | NCT04135573

Studies
The Relationship Between NK Cell and Graves' Disease

NCT04135573

Sponsor

Shandong Provincial Hospital

Status

Unknown status

Last Update Posted

Apr 14, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Graves 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

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2018Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Jan 3, 2019

First Submission Date that Met QC Criteria

Oct 20, 2019

First Posted Date

Oct 22, 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

Graves' disease (GD) is one of organ specific autoimmune diseases, the pathogenesis is not elucidated.Natural Killer (Natural Killer, NK) cells is a kind of important immune regulator, several abnormalities of NK cell function and number in GD patients have been described in the investigators' previous study. It is remain unclear whether the NK cell disfunction is a consequence of GD.Based on the investigators' previous study, the investigators plan to monitor NK cell function in participants in the whole course of disease, analyze the association with relevant factors, such as thyroid function, immune state or treatment,to find out influences of thyroid hormones and thyroid receptor antibody affecting the function of NK cell. The investigators will reveal whether the disfunction of NK cell secondary to GD abnormal thyroid function and/or immune disorders, and realize the mechanics.

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

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
New untreated GD patients		Before treatment and application of anti-thyroid drugs (methimazole) or radioactive iodine treatment
Healthy control		No thyroid related diseases and other immune diseases

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number and function of NK cells changes of hyperthyroidism	Flow cytometry used to measure the related changes of NK cells in hyperthyroidism	measured after 2 years of follow-up

Secondary Outcomes

Measure	Description	Time Frame
Changes in serum levels	Detection of related cytokines by ELISA	measured after 2 years of follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

New GD patients without any treatment
Aged of 18 to 75 years old

Exclusion Criteria:

Pregnant or lactating woman;
Known autoimmune disease;
Receiving psychotropic or hormonal drugs;
Taking drugs that affect the body's immune function;
Obviously poor compliance.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Adults aged of 18 to 75 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haiqing Zhang	Shandong Provincial Hospital	Study Chair

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006111	Graves Disease

Ancestor Terms

ID	Term
D005094	Exophthalmos
D009916	Orbital Diseases
D005128	Eye Diseases
D006042	Goiter

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Browse Branches

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