Graves DiseaseNCT04135573
The Relationship Between NK Cell and Graves' Disease
An observational study of Graves Disease, run by Shandong Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Graves Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2018to 30 Jun 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged of 18 to 75 years old
Who may be able to join
- New GD patients without any treatment
- Aged of 18 to 75 years old
Who cannot join
- Pregnant or lactating woman;
- Known autoimmune disease;
- Receiving psychotropic or hormonal drugs;
- Taking drugs that affect the body's immune function;
- Obviously poor compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanism of NK Cell Disfunction in Graves' Disease
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.
- Conditions
- Graves Disease
- Keywords
- Atuoimmune thyroid disease, Graves' disease, Natural killer cell
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and function of NK cells changes of hyperthyroidism
Flow cytometry used to measure the related changes of NK cells in hyperthyroidism
Measured: measured after 2 years of follow-up
Secondary outcomes (1)
Changes in serum levels
Detection of related cytokines by ELISA
Measured: measured after 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start15 Oct 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hai-qing Zhang, Shandong Provincial Hospital
- Investigators
- Haiqing Zhang, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135573
- Sponsor's protocol ID
- 2018109
- Status last verified
- Apr 2021
- First submitted
- 3 Jan 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of NK Cell Disfunction in Graves' Disease
- ClinicalTrials.gov ID
- NCT04135573
- Acronym / sponsor ID
- 2018109
- Conditions
- Graves Disease
- Keywords
- Atuoimmune thyroid disease, Graves' disease, Natural killer cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged of 18 to 75 years old
Key inclusion criteria (2 listed)
- New GD patients without any treatment
- Aged of 18 to 75 years old
Key exclusion criteria (5 listed)
- Pregnant or lactating woman;
- Known autoimmune disease;
- Receiving psychotropic or hormonal drugs;
- Taking drugs that affect the body's immune function;
- Obviously poor compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number and function of NK cells changes of hyperthyroidism
Time frame: measured after 2 years of follow-up
Flow cytometry used to measure the related changes of NK cells in hyperthyroidism
1 secondary outcome
Changes in serum levels
Time frame: measured after 2 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiqing Zhang study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and function of NK cells changes of hyperthyroidism (time frame: measured after 2 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.