Autoimmune Thyroid DiseaseNCT04075851
The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases
An observational study of Autoimmune Thyroid Disease, run by Shandong Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Thyroid Disease
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 1 Aug 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Autoimmune thyroid diseases in endocrine outpatient department of shandong provincial hospital from August 1, 2019 to August 1, 2022
Who may be able to join
- male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old
Who cannot join
- Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Province Hospital
Jinan, Shandong, 250021
Haiqing Zhang, 86-53-68776094, 15168888303@163.com
About this study
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.
- Conditions
- Autoimmune Thyroid Disease
- Keywords
- Autoimmune thyroid disease, Thyroid hormone autoantibodies, Hashimoto's thyroiditis, Grave's disease
- Medical subject headings
- Hashimoto 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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of thyroid hormone autoantibodies in AITD
Radioimmuno precipitation test used for thyroid hormone autoantibodies
Measured: measured after 1 year 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 posted3 Sep 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Thyroid 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
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 province hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075851
- Sponsor's protocol ID
- 20190801
- Status last verified
- Apr 2021
- First submitted
- 29 Aug 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
- The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases
- ClinicalTrials.gov ID
- NCT04075851
- Acronym / sponsor ID
- 20190801
- Conditions
- Autoimmune Thyroid Disease
- Keywords
- Autoimmune thyroid disease, Thyroid hormone autoantibodies, Hashimoto's thyroiditis, Grave's disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 3 Sep 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Autoimmune thyroid diseases in endocrine outpatient department of shandong provincial hospital from August 1, 2019 to August 1, 2022
Key inclusion criteria (1 listed)
- male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old
Key exclusion criteria (1 listed)
- Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system
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
prevalence of thyroid hormone autoantibodies in AITD
Time frame: measured after 1 year of follow-up
Radioimmuno precipitation test used for thyroid hormone autoantibodies
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 province 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 Autoimmune Thyroid 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 1 inclusion and 1 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?
Contact Ling Gao (+86 53168776910, gaoling1@medmall.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of thyroid hormone autoantibodies in AITD (time frame: measured after 1 year 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.