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Completed

NCT Number: NCT05713097

TSI and Its Relationship With Graves' 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:

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.

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Key information

Conditions

Graves Disease Anti-Thyroid Antibodies Disorder Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Immunoglobulin Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hoa Hao Clinic

Ho Chi Minh City, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TSI

Diagnostic Test

TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).

Primary outcomes

  1. Number of Participants with GD relapse

    Time frame: at least 1 year after ATD withdrawal

    Patients who had relapse of hyperthyroidism due to GD

Secondary outcomes

  1. TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.

    Time frame: before ATD withdrawal

    TSI level before planning for ATD withdrawal

  2. Optimal cut-off of TSI level for predicting GD relapse

    Time frame: before ATD withdrawal

    Optimal cut-off of TSI level before ATD withdrawal for predicting GD relapse

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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