Human Papillomavirus InfectionNCT02188004
The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases
An observational study of Human Papillomavirus Infection and Genital Warts, run by Jun Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection, Genital Warts
- How many people
- 4,691 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to May 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 5000 healthy volunteers will be recruited from the residents of Liuzhou through advertisment.
Who may be able to join
- 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.
Who cannot join
- pregnant;
- has received HPV vaccines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases In Male and Female Aged Over 18 Years In China
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.
- Conditions
- Human Papillomavirus Infection, Genital Warts
- Keywords
- HPV, genital warts
- Medical subject headings
- Papillomavirus Infections, Condylomata Acuminata
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and incidence of HPV infection
Evaluate the prevalence and incidence of HPV infection and related diseases in subjects
Measured: 1 year
Secondary outcomes (1)
risk factors of HPV infection and related diseases
Analyze risk factors of HPV infection and related diseases.
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 posted11 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies 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
- 4,691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Liuzhou center of disease prevention and control
- Responsible party
- Sponsor-investigator, Jun Zhang, Xiamen University
- Investigators
- Jun Zhang, Study chair, Xiamen UniversityMing-Qiang Li, Principal investigator, Liuzhou center of disease prevention and control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188004
- Sponsor's protocol ID
- HPV-EPI-001
- Status last verified
- May 2019
- First submitted
- 9 Jul 2014
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30852604
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases In Male and Female Aged Over 18 Years In China
- ClinicalTrials.gov ID
- NCT02188004
- Acronym / sponsor ID
- HPV-EPI-001
- Conditions
- Human Papillomavirus Infection, Genital Warts
- Keywords
- HPV, genital warts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,691 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Collaborators
- Liuzhou center of disease prevention and control
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Jul 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 5000 healthy volunteers will be recruited from the residents of Liuzhou through advertisment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- pregnant;
- has received HPV vaccines.
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
prevalence and incidence of HPV infection
Time frame: 1 year
Evaluate the prevalence and incidence of HPV infection and related diseases in subjects
1 secondary outcome
risk factors of HPV infection and related diseases
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 7 May 2019.
- Derived from this study: PubMed 30852604Wei 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.
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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.
Jun Zhang study chair
Xiamen University
Ming-Qiang Li principal investigator
Liuzhou center of disease prevention and control
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 Human Papillomavirus Infection and Genital Warts, 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 4 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: finished, as of the sponsor's last update on 7 May 2019. 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?
prevalence and incidence of HPV infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188004, which also lists 1 linked publication.
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 7 May 2019.