Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

EBV Infection Clinical Trial

Official title:

A Prospective Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782674
• Other study ID #: saliva EBV-DNA
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: April 2022

Study information

• Verified date: March 2022
• Source: Beijing Friendship Hospital
• Contact: Zhao Wang, Dr
• Phone: +8618810253070
• Email: wangzhao[@]ccmue.du.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 65 Years

Eligibility

Inclusion Criteria:

1. According to the HLH-04 diagnostic criteria, it meets the HLH diagnostic criteria. EBV infection occurs in cells with EBV-DNA copy number significantly increased in peripheral blood or tissue, or where EBV coding small RNA(EBER) is detected in tissue or peripheral blood. Or Straus' 1988 diagnostic criteria for CAEBV.

2. Informed consent

Exclusion Criteria:

1. Patients who cannot cooperate with saliva collection

2. Patients who are unwilling to cooperate with the project research according to the project research plan.

Related Conditions & MeSH terms

• Communicable Diseases
• EBV Infection
• Epstein-Barr Virus Infections
• Infections

Intervention

Diagnostic Test:
• Saliva Testing
Saliva EBV-DNA Detection comparing with PBMC and plasma EBV-DNA

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis	The sensitivity and specificity of saliva EBV-DNA detection level as a diagnosis for EBV infection-related diseases, and whether it can replace peripheral blood EBV-DNA monitoring	baseline
Primary	Monitoring	The sensitivity and specificity of saliva EBV-DNA detection level as a monitoring method for EBV infection-related diseases, and whether it can replace peripheral blood EBV-DNA monitoring	2 to 12 weeks after treatment