EBV InfectionNCT04782674
Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases
An observational study of EBV Infection, run by Beijing Friendship Hospital at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- EBV Infection
- What is being tested?
- Saliva Testing
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2021to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffer EBV infection related disease
Who may be able to join
- 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.
- Informed consent
Who cannot join
- Patients who cannot cooperate with saliva collection
- Patients who are unwilling to cooperate with the project research according to the project research plan.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Yue Song, M.M., 86-18810253070 ext. +8601063139862, xueqifeng1992@163.com
About this study
Official title: A Prospective Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases
This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases
- Conditions
- EBV Infection
- Being tested
- Saliva Testing
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva TestingDiagnostic test
Saliva EBV-DNA Detection comparing with PBMC and plasma EBV-DNA
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
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
Measured: 2 to 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Mar 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV InfectionStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Wang, Beijing Friendship Hospital
- Investigators
- Zhao Wang, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782674
- Sponsor's protocol ID
- saliva EBV-DNA
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases
- ClinicalTrials.gov ID
- NCT04782674
- Acronym / sponsor ID
- saliva EBV-DNA
- Conditions
- EBV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffer EBV infection related disease
Key inclusion criteria (2 listed)
- 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.
- Informed consent
Key exclusion criteria (2 listed)
- Patients who cannot cooperate with saliva collection
- Patients who are unwilling to cooperate with the project research according to the project research plan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva TestingSaliva EBV-DNA Detection comparing with PBMC and plasma EBV-DNA | Diagnostic test | – |
Primary outcome
Diagnosis
Time frame: 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
Monitoring
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Wang principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EBV Infection, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao Wang, Dr (+8618810253070, wangzhao@ccmue.du.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.