The Epidemiologic Study of Human Cytomegalovirus（CMV） in... | NCT02642822

Studies
The Epidemiologic Study of Human Cytomegalovirus（CMV） in Female Students of Xiamen University

NCT02642822

Sponsor

Jun Zhang

Status

Completed

Last Update Posted

Jul 14, 2016Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Cytomegalovirus Infections

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Dec 24, 2015

First Submission Date that Met QC Criteria

Dec 29, 2015

First Posted Date

Dec 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of active CMV infection in different PP150-IgG titer		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-30 years old
female students of Xiamen University

Exclusion Criteria:

students who have the serious diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

100 female students aged 18 to 30 years old will be recruited from Xiamen University.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of public health of Xiamen University		Xiamen	Fujian	361000	China

Condition Browse Module

MeSH Terms

ID	Term
D003586	Cytomegalovirus Infections

Ancestor Terms

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided