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Status unknownNCT04782674Updated Mar 31, 2022

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

An observational study in EBV Infection, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 3 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Beijing Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
3 Years to 65 Years
Sex
All
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Study 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

02

Conditions studied

  • EBV Infection
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 40 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

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

04

Who can participate

Ages eligible
3 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suffer EBV infection related disease

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testSaliva Testing

    Saliva EBV-DNA Detection comparing with PBMC and plasma EBV-DNA

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

  2. 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

    Time frame: 2 to 12 weeks after treatment

07

Study locations

1 of 1 sites recruiting
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04782674
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Principal Investigator, Beijing Friendship Hospital) — Principal investigator
First posted
Mar 4, 2021
Start date
Mar 15, 2021
Primary completion
Apr 2022 (estimated)
Completion
Apr 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Zhao Wang, Dr
Contact
wangzhao@ccmue.du.cn
+8618810253070
Zhao Wang
principal investigator · Beijing Friendship Hospital

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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