Clinical trial NCT05713097: TSI and Its Relationship With Graves' Disease Relapse
Official title: Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Disease
Immunoglobulin
Anti-Thyroid Antibodies Disorder
Keywords: TSI
recurrent Graves' disease
Graves' ophthalmopathy
treatment duration
anti-thyroid drug
cut-off
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.
2. To determine an optimal cut-off of TSI level for predicting GD relapse.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants with GD relapse
timeFrame: at least 1 year after ATD withdrawal
Secondary outcomes:
measure: TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.
timeFrame: before ATD withdrawal
measure: Optimal cut-off of TSI level for predicting GD relapse
timeFrame: before ATD withdrawal
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Hoa Hao Clinic
Study officials:
affiliation: University of Medecine and Pharmacy at Ho Chi Minh City
name: Vu Nhat Phong Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: