Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation

Not yet recruiting

• Conditions: Graves' Disease in Remission; Graves Disease; Epstein-Barr Virus

• Registration Number: NCT06426758
• Lead Sponsor: Xiao-Ming Mao

Brief Summary

Previous studies have proved that the lytic reactivation of latent Epstein-Barr virus (EBV) was significantly associated with the onset of Graves'disease (GD), however, the morbidity of GD and recurrence rate of hyperthyroidism after antithyroid drugs treatment due to lytic reactivation of EBV is not understood. We will recruit patients with newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment. In order to confirm lytic reactivation of EBV, the number of EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic EBV genes，EBV +TRAb+cells will be tested. The proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism was evaluated.

Detailed Description

The lytic reactivation of latent EBV play importment roles in development of GD and recurrence rate of hyperthyroidism. The aim of this study is to evaluate the proportion of lytic reactivation of EBV in newly diagnosed GD and recurrence of hyperthyroidism.

All patients satisfied the diagnostic criteria for GD. The diagnotic remission of hyperthyroidism was included of clinical symptoms and elevated FT3 and FT4, the patients who have been received antithyroid drugs (methimazole or propylthiouracil) titration treatment for 18 or more months and of antithyroid drugs titration treatment and withdrawal antithyroid drugs at least 3 months.

The evaluation of lytic reactivation of latent EBV including EBV DNA copies，mRNA and protein expression of immediate-early, early and late lytic genes，and EBV +TRAb+cells. The EBV DNA copies was tested with PCR, mRNA and protein expression of immediate-early, early and late lytic EBV genes were analysed with RT-qPCR or Western blot and EBV +TRAb+cells were evaluated with flow cytometry.

All statistical tests were performed using GraphPad Prism V8.0.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-19
• Study First Submitted QC: 2024-05-19
• Last Update Submitted: 2024-05-19
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Study Start: 2024-05-30
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• The clinical evaluation included patient history, physical examination, and thyroid ultrasonography. Laboratory and diagnostic testing included determination of serum levels of free thyroxine (FT4), T3 ( FT3), thyrotropin (TSH), TPOAb, TGAb, and serum levels of thyrotropin receptor antibody (TRAb).

Exclusion Criteria

• Patients with subacute thyroiditis, hyperfunctioning thyroid nodules, iodine hyperthyroidism, drug-induced hyperthyroidism, or other causes of hyperthyroidism were also excluded. The exclusion criteria for both patients with GD included diabetes, infectious diseases, other chronic diseases, and cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence rate of GD and and recurrence of hyperthyroidism due to lytic reactivation of EBV	3 years	The GD patients with high number of EBV DNA copies, EBV +TRAb+cells and overexpression lytic genes are considered as lytic reactivation of EBV

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China