NCT02188004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,691

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

July 9, 2014

Last Update Submit

May 5, 2019

Conditions

Human Papillomavirus InfectionGenital Warts

Keywords

HPVgenital warts

Outcome Measures

Primary Outcomes (1)

  • prevalence and incidence of HPV infection

    Evaluate the prevalence and incidence of HPV infection and related diseases in subjects

    1 year

Secondary Outcomes (1)

  • risk factors of HPV infection and related diseases

    1 year

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant;
  • has received HPV vaccines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liuzhou Center of disease prevention and control

Liuchow, Guangxi, China

Location

Related Publications (1)

  • 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.

    PMID: 30852604DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Male:Two swabs were used to collect exfoliated skin cells from the coronal sulcus /glans/shaft and anal Female:Three swabs were used to collect exfoliated skin cells from the vagina，vulva and anal

MeSH Terms

Conditions

Papillomavirus InfectionsCondylomata Acuminata

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWartsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jun Zhang

    Xiamen University

    STUDY CHAIR

  • Ming-Qiang Li

    Liuzhou center of disease prevention and control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 11, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

CN(1)