Graves DiseaseNCT05713097
TSI and Its Relationship With Graves' Disease Relapse
An observational study of Graves Disease and Immunoglobulin, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease, Immunoglobulin, Anti-Thyroid Antibodies Disorder
- What is being tested?
- TSI
- How many people
- 352 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Jan 2022to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City, Vietnam from January 2000 to April 2021.
Who may be able to join
- Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association.
- TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg.
Who cannot join
- Hyperthyroidism due to other causes
- Patients who were intolerant to ATD or had serious side effects with ATD.
- TSIs were measured in pregnancy.
- Patients treated with surgery or radioactive iodine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse
The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are:
- To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.
- To determine an optimal cut-off of TSI level for predicting GD relapse.
- To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.
Read the detailed description
Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.
- Being tested
- TSI
- Keywords
- TSI, recurrent Graves' disease, Graves' ophthalmopathy, treatment duration, anti-thyroid drug, cut-off
- Medical subject headings
- Graves Disease, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSIDiagnostic test
TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).
| Study group | Role | What they receive |
|---|---|---|
| ATD withdrawal | ATD treatment was decided to be stopped at the discretion of the attending physician. Then, patients were followed after ATD withdrawal to determine who would have relapse of GD.
Finally, patients were divided into 2 groups: Relapse and No relapse Receives: Diagnostic Test: TSI | |
| No ATD withdrawal | Patients treated with ATD still the end of the study Receives: Diagnostic Test: TSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with GD relapse
Patients who had relapse of hyperthyroidism due to GD
Measured: at least 1 year after ATD withdrawal
Secondary outcomes (2)
TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.
TSI level before planning for ATD withdrawal
Measured: before ATD withdrawal
Optimal cut-off of TSI level for predicting GD relapse
Optimal cut-off of TSI level before ATD withdrawal for predicting GD relapse
Measured: before ATD withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start2 Jan 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phong VN Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Vu Nhat Phong Nguyen, MD, Principal investigator, University of Medecine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713097
- Sponsor's protocol ID
- TSI_Medic
- Status last verified
- Feb 2023
- First submitted
- 13 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse
- ClinicalTrials.gov ID
- NCT05713097
- Acronym / sponsor ID
- TSI_Medic
- Keywords
- TSI, recurrent Graves' disease, Graves' ophthalmopathy, treatment duration, anti-thyroid drug, cut-off
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Feb 2023 (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.
The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are:
- To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.
- To determine an optimal cut-off of TSI level for predicting GD relapse.
- To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.
Detailed description
Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATD withdrawal | – | Diagnostic Test: TSIATD treatment was decided to be stopped at the discretion of the attending physician. Then, patients were followed after ATD withdrawal to determine who would have relapse of GD. Finally, patients were divided into 2 groups: Relapse and No relapse |
| No ATD withdrawal | – | Diagnostic Test: TSIPatients treated with ATD still the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City, Vietnam from January 2000 to April 2021.
Key inclusion criteria (2 listed)
- Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association.
- TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg.
Key exclusion criteria (4 listed)
- Hyperthyroidism due to other causes
- Patients who were intolerant to ATD or had serious side effects with ATD.
- TSIs were measured in pregnancy.
- Patients treated with surgery or radioactive iodine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSITSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). | Diagnostic test | ATD withdrawal, No ATD withdrawal |
Primary outcome
Number of Participants with GD relapse
Time frame: at least 1 year after ATD withdrawal
Patients who had relapse of hyperthyroidism due to GD
2 secondary outcomes
TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.
Time frame: before ATD withdrawal
Optimal cut-off of TSI level for predicting GD relapse
Time frame: before ATD withdrawal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Vu Nhat Phong Nguyen, MD principal investigator
University of Medecine and Pharmacy at Ho Chi Minh City
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 and Immunoglobulin, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 4 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: finished, as of the sponsor's last update on 6 Feb 2023. 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with GD relapse (time frame: at least 1 year after ATD withdrawal). 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 6 Feb 2023.