Graves' Disease Induced by Epstein-Barr Virus Lytic React... | NCT06426758

Studies
Graves' Disease Induced by Epstein-Barr Virus Lytic Reactivation

NCT06426758

Sponsor

Xiao-Ming Mao

Status

Not yet recruiting

Last Update Posted

May 23, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Graves Disease
Graves' Disease in Remission
Epstein-Barr Virus

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2024Estimated

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2027Estimated

First Submitted Date

May 19, 2024

First Submission Date that Met QC Criteria

May 19, 2024

First Posted Date

May 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2024

Last Update Posted Date

May 23, 2024Actual

Name	Class
National Natural Science Foundation of China	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Newly diagnosed GD and recurrence of hyperthyroidism after antithyroid drugs treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing First Hospital, Nanjing Medical University		Nanjing	Jiangsu	210006	China

Condition Browse Module

MeSH Terms

ID	Term
D006111	Graves Disease
D020031	Epstein-Barr Virus Infections

Ancestor Terms

ID	Term
D005094	Exophthalmos
D009916	Orbital Diseases
D005128	Eye Diseases
D006042	Goiter

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.