Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-05 @ 9:40 PM
Study NCT ID:
NCT06426758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation
Sponsor:
Xiao-Ming Mao
Organization:
Study Overview
Official Title:
The Morbidity of Graves' Disease and Recurrence Rate of Hyperthyroidism Due to Epstein-Barr Virus Lytic Reactivation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: