The Epidemiologic Study of Human Papillomavirus Infection... | NCT02188004

Studies
The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases

NCT02188004

Sponsor

Jun Zhang

Status

Completed

Last Update Posted

May 7, 2019Actual

Enrollment

4,691Actual

Phase

Not provided

Conditions

Human Papillomavirus Infection
Genital Warts

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

May 2019

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

Jun 2014

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jul 9, 2014

First Submission Date that Met QC Criteria

Jul 9, 2014

First Posted Date

Jul 11, 2014Estimated

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

May 5, 2019

Last Update Posted Date

May 7, 2019Actual

Name	Class
Liuzhou center of disease prevention and control	UNKNOWN

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

primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases in subjects.

Secondary purpose:Analyze risk factors of HPV infection and related diseases.

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

Retention

Enrollment

4,691Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence and incidence of HPV infection	Evaluate the prevalence and incidence of HPV infection and related diseases in subjects	1 year

Secondary Outcomes

Measure	Description	Time Frame
risk factors of HPV infection and related diseases	Analyze risk factors of HPV infection and related diseases.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ages 18 to 55 years;
residents of the study site;
at least one sex partner;
Be able to understand and comply with the request of the protocol.

Exclusion Criteria:

pregnant;
has received HPV vaccines.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

5000 healthy volunteers will be recruited from the residents of Liuzhou through advertisment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Zhang	Xiamen University	Study Chair
Ming-Qiang Li	Liuzhou center of disease prevention and control	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liuzhou Center of disease prevention and control		Liuzhou	Guangxi		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30852604	Derived	Wei F, Guo M, Huang S, Li M, Cui X, Su Y, Wu X, Ma X, Zheng Y, Huang Y, Wang L, Pan L, Wu T, Zhang J, Xia N. Sex Differences in the Incidence and Clearance of Anogenital Human Papillomavirus Infection in Liuzhou, China: An Observational Cohort Study. Clin Infect Dis. 2020 Jan 1;70(1):82-89. doi: 10.1093/cid/ciz168.

ID	Term
D030361	Papillomavirus Infections
D003218	Condylomata Acuminata

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections