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Not yet recruitingNCT06426758Updated May 23, 2024

Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation

An observational study in Graves Disease, Graves' Disease in Remission and Epstein-Barr Virus, sponsored by Xiao-Ming Mao. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Xiao-Ming Mao · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Graves Disease
  • Graves' Disease in Remission
  • Epstein-Barr Virus

Keywords

  • Graves Disease
  • Relapse of hyperthyroidism
  • Epstein-Barr virus
  • Lytic reactivation
  • Morbidity
03

In context

Graves Disease

162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's planned enrollment of 300 is above the median of 120 across 56 observational studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Xiao-Ming Mao is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2024; primary completion for Sep 2026, 27 months later.

Of 18 observational studies under Graves Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 118. This study's planned 27 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2024
First posted
May 23, 2024
StartEst.
May 30, 2024
Primary completionEst.
Sep 1, 2026
CompletionEst.
Sep 1, 2027
Last update
May 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06426758
Lead sponsor
Xiao-Ming Mao
Collaborators
National Natural Science Foundation of China
Responsible party
Xiao-Ming Mao (Professor, Nanjing Medical University) — Sponsor-investigator
First posted
May 23, 2024
Start date
May 30, 2024 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
May 23, 2024

Study contacts

Xiao-Ming Mao, MD.
Contact
maoxming@163.com
+86-18951670295
Guo-Qing Li, PhD.
Contact
liguqi941001@163.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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