Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation

NCT06426758 | Not Yet Recruiting DMC

• 1 other identifier: NanjingMU2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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

  3 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment

You may qualify if:

• 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).

Sponsors & Collaborators

• Xiao-Ming Mao: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Following DNA isolation with a QIAamp DNA Blood Mini Kit, the number of EBV copies in PBMCs was detected using real-time PCR assay by means of the ISEX variant of the EBV PCR kit. The results are expressed in units of EBV DNA copies/µg of DNA, EBV DNA copies/mL of PBMCs suspension, and EBV DNAcopies/100,000 cells. Peripheral blood samples were collected from patients with GD and recurrence of hyperthyroidism.Total RNA was extracted from blood using the conventional TRIzol method. Reverse transcription was performed using PrimeScript RT Reagent Kit with cDNA Eraser for two-step reverse transcription polymerase chain reaction.

MeSH Terms

Conditions

Graves Disease; Epstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Central Study Contacts

Xiao-Ming Mao, MD.

CONTACT

+86-18951670295; maoxming@163.com

Guo-Qing Li, PhD.

CONTACT

liguqi941001@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

CN (1)