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

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04782674
Collaborator
(none)
40
Enrollment
1
Location
12.6
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Saliva Testing

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Prospective Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases
Actual Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Diagnosis [baseline]

    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

  2. Monitoring [2 to 12 weeks after treatment]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050

Sponsors and Collaborators

  • Beijing Friendship Hospital

Investigators

  • Principal Investigator: Zhao Wang, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Wang, Principal Investigator, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT04782674
Other Study ID Numbers:
  • saliva EBV-DNA
First Posted:
Mar 4, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
Epstein-Barr Virus Infections

Study Results

No Results Posted as of Mar 31, 2022