Clinical trial NCT06426758: Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation
Official title: The Morbidity of Graves' Disease and Recurrence Rate of Hyperthyroidism Due to Epstein-Barr Virus Lytic Reactivation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Graves Disease
Graves' Disease in Remission
Epstein-Barr Virus
Keywords: Graves Disease
Relapse of hyperthyroidism
Epstein-Barr virus
Lytic reactivation
Morbidity
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-05-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence rate of GD and and recurrence of hyperthyroidism due to lytic reactivation of EBV
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
References: