NCT04135573

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

January 3, 2019

Last Update Submit

April 12, 2021

Conditions

Keywords

Atuoimmune thyroid diseaseGraves' diseaseNatural killer cell

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Changes in serum levels

    measured after 2 years of follow-up

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults aged of 18 to 75 years old

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum,whole blood

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Officials

  • Haiqing Zhang

    Shandong Provincial Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 3, 2019

First Posted

October 22, 2019

Study Start

October 15, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations