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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06426758
Other study ID # NanjingMU2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 30, 2024
Est. completion date September 1, 2027

Study information

Verified date May 2024
Source Nanjing Medical University
Contact Xiao-Ming Mao, MD.
Phone +86-18951670295
Email maoxming@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date September 1, 2027
Est. primary completion date September 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Locations

Country Name City State
China Nanjing First Hospital, Nanjing Medical University Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Xiao-Ming Mao National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence rate of GD and and recurrence of hyperthyroidism due to lytic reactivation of EBV The GD patients with high number of EBV DNA copies, EBV +TRAb+cells and overexpression lytic genes are considered as lytic reactivation of EBV 3 years
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