Cytomegalovirus InfectionsNCT02642822
The Epidemiologic Study of Human Cytomegalovirus（CMV） in Female Students of Xiamen University
An observational study of Cytomegalovirus Infections, run by Jun Zhang at 1 site in China.
Trial summary
In this study, 100 female students aged 18 to 30 years old in Xiamen University will be enrolled. On the first visit, blood, saliva and urine samples of all participants will be collected. Then saliva and urine samples will be collected at two-week interval until 6 months. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Apr 2016
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 100 female students aged 18 to 30 years old will be recruited from Xiamen University.
Who may be able to join
- 18-30 years old
- female students of Xiamen University
Who cannot join
- students who have the serious diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Epidemiologic Study of Human Cytomegalovirus （CMV）in Female Students of Xiamen University
In this study, 100 female students aged 18 to 30 years old in Xiamen University will be enrolled. On the first visit, blood, saliva and urine samples of all participants will be collected. Then saliva and urine samples will be collected at two-week interval until 6 months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be used to test CMV DNA by PCR. The primary purpose of this study is to identify the relationship between baseline PP150-IgG titer and CMV infection.
- Conditions
- Cytomegalovirus Infections
- Keywords
- Cytomegalovirus
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of active CMV infection in different PP150-IgG titer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Zhang, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642822
- Sponsor's protocol ID
- CMV-EPI-002
- Status last verified
- Dec 2015
- First submitted
- 24 Dec 2015
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiologic Study of Human Cytomegalovirus （CMV）in Female Students of Xiamen University
- ClinicalTrials.gov ID
- NCT02642822
- Acronym / sponsor ID
- CMV-EPI-002
- Conditions
- Cytomegalovirus Infections
- Keywords
- Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- 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.
In this study, 100 female students aged 18 to 30 years old in Xiamen University will be enrolled. On the first visit, blood, saliva and urine samples of all participants will be collected. Then saliva and urine samples will be collected at two-week interval until 6 months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be used to test CMV DNA by PCR. The primary purpose of this study is to identify the relationship between baseline PP150-IgG titer and CMV infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 female students aged 18 to 30 years old will be recruited from Xiamen University.
Key inclusion criteria (2 listed)
- 18-30 years old
- female students of Xiamen University
Key exclusion criteria (1 listed)
- students who have the serious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of active CMV infection in different PP150-IgG titer
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cytomegalovirus Infections, run by Jun Zhang 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 1 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: finished, as of the sponsor's last update on 14 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of active CMV infection in different PP150-IgG titer (time frame: 1 year). 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 14 Jul 2016.