the High-Risk HPV InfectionNCT03577925
The Standard Management of HPV Infection
An observational study of the High-Risk HPV Infection, run by Capital Medical University at 1 site in China.
Trial summary
High-risk human papillomavirus (HR-HPV) infection is a necessary condition in the occurence and development of cervical squamous intraepithelial lesion (SIL) and cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- the High-Risk HPV Infection
- What is being tested?
- HPV genotype test
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 30 Jun 2019
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: the HR-HPV genotype tested positive patients with HSIL or stage IA1 cervical squamous cancer who received conization at genocology oncology department in Beijing Obstetrics and Gynecology Hospital during Oct 2016 to Oct 2018.
Who may be able to join
- age not above 70
- histologically diagnosed as HSIL or stage IA1 cervical squamous cancer
- received conization in Beijing Obstetrics and Gynecology Hospital
- HR-HPV infected without any treatment other than conization
- HR-HPV genotype tested before coniztion
Who cannot join
- age above 70
- with severe desease that influence the follow-up
- received other treatment on cervical lesion
- data incompleted
- not meet the inclusive criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yu mei Wu
Beijing, Beijing Municipality
Yu mei Wu, Doctor
About this study
Official title: The Standard Mangagement of High-Risk HPV Infection During Follow-up Visits
High-risk human papillomavirus (HR-HPV) infection is a necessary condition in the occurence and development of cervical squamous intraepithelial lesion (SIL) and cervical cancer. There are cases that high-grade SIL (HSIL) and stage IA1 cervical squamous cancer remain or reoccur, or even become more severe after conization. The infection situation of HR-HPV, which plays an important role in the prognosis of cervical lesion, should be consulted in the management and follw-up after conization. It is worthwhile making further study in the specific practical significance of the HR-HPV in the prognosis of cervical lesion, as well as the high-risk factors that influence the prognosis of HR-HPV.
Read the detailed description
Main purpose:To work out the standard management of HPV infection by following up the HPV infection situation of the patients with high-grade SIL (HSIL) and stage IA1 cervical squamous cancer after conization.
Research design:First, to do the retrospective analysis toward the patients who received conization between Jan 2009 to Aug 2016.Second,to do the prospective analysis toward the patients who received conization between Spt 2016 to Aug 2018.
Inclusive criteria of study population:The patients who had finished HPV genotype testing before conization;who had never received treatment other than conization;who were histologically diagnosed as HSIL or IA1 cervical squamous cancer;who had not been diagnosed as any cervical diseases before;who were under age 70;who did not have any severe diseases that influence the follow-up.
Follow-up methods:to do the follow-up to the target patients by 3,6,9,12,18,24 months after conization.
Follow-up contents:the HR-HPV genotype infection before conization;the grade of lesion;the age when received conization;the gravity and parity;the situation of the glands invovement
- Conditions
- the High-Risk HPV Infection
- Being tested
- HPV genotype test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV genotype testDiagnostic test
HPV genotype test is a diagnostic test by smearing the cervix to find out whether a patient is hpv infected, and if infected, the test can descover the concrete hpv genotype.
| Study group | Role | What they receive |
|---|---|---|
| HSIL | the patients with HSIL Receives: Diagnostic Test: HPV genotype test | |
| stage IA1 cervical squamous cancer | the patients with stage IA1 cervical squamous cancer Receives: Diagnostic Test: HPV genotype test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The HR-HPV clearance
The difference of the HR-HPV clearance between HSIL and stage IA1 cervical squamous cancer
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 Oct 2016
- Primary completion1 Oct 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the High-Risk HPV InfectionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu mei Wu, Capital Medical University
- Investigators
- Yu mei Wu, Doctor, Study director, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577925
- Sponsor's protocol ID
- ZYLX201705
- Status last verified
- Jun 2018
- First submitted
- 24 Jun 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Standard Mangagement of High-Risk HPV Infection During Follow-up Visits
- ClinicalTrials.gov ID
- NCT03577925
- Acronym / sponsor ID
- ZYLX201705
- Conditions
- the High-Risk HPV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 5 Jul 2018 (actual)
- 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.
High-risk human papillomavirus (HR-HPV) infection is a necessary condition in the occurence and development of cervical squamous intraepithelial lesion (SIL) and cervical cancer. There are cases that high-grade SIL (HSIL) and stage IA1 cervical squamous cancer remain or reoccur, or even become more severe after conization. The infection situation of HR-HPV, which plays an important role in the prognosis of cervical lesion, should be consulted in the management and follw-up after conization. It is worthwhile making further study in the specific practical significance of the HR-HPV in the prognosis of cervical lesion, as well as the high-risk factors that influence the prognosis of HR-HPV.
Detailed description
Main purpose:To work out the standard management of HPV infection by following up the HPV infection situation of the patients with high-grade SIL (HSIL) and stage IA1 cervical squamous cancer after conization.
Research design:First, to do the retrospective analysis toward the patients who received conization between Jan 2009 to Aug 2016.Second,to do the prospective analysis toward the patients who received conization between Spt 2016 to Aug 2018.
Inclusive criteria of study population:The patients who had finished HPV genotype testing before conization;who had never received treatment other than conization;who were histologically diagnosed as HSIL or IA1 cervical squamous cancer;who had not been diagnosed as any cervical diseases before;who were under age 70;who did not have any severe diseases that influence the follow-up.
Follow-up methods:to do the follow-up to the target patients by 3,6,9,12,18,24 months after conization.
Follow-up contents:the HR-HPV genotype infection before conization;the grade of lesion;the age when received conization;the gravity and parity;the situation of the glands invovement
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSIL | – | Diagnostic Test: HPV genotype testthe patients with HSIL |
| stage IA1 cervical squamous cancer | – | Diagnostic Test: HPV genotype testthe patients with stage IA1 cervical squamous cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the HR-HPV genotype tested positive patients with HSIL or stage IA1 cervical squamous cancer who received conization at genocology oncology department in Beijing Obstetrics and Gynecology Hospital during Oct 2016 to Oct 2018.
Key inclusion criteria (5 listed)
- age not above 70
- histologically diagnosed as HSIL or stage IA1 cervical squamous cancer
- received conization in Beijing Obstetrics and Gynecology Hospital
- HR-HPV infected without any treatment other than conization
- HR-HPV genotype tested before coniztion
Key exclusion criteria (5 listed)
- age above 70
- with severe desease that influence the follow-up
- received other treatment on cervical lesion
- data incompleted
- not meet the inclusive criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV genotype testHPV genotype test is a diagnostic test by smearing the cervix to find out whether a patient is hpv infected, and if infected, the test can descover the concrete hpv genotype. | Diagnostic test | HSIL, stage IA1 cervical squamous cancer |
Primary outcome
The HR-HPV clearance
Time frame: 24 months
The difference of the HR-HPV clearance between HSIL and stage IA1 cervical squamous cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yu mei Wu, Doctor study director
Beijing Obstetrics and Gynecology Hospital
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 the High-Risk HPV Infection, run by Capital Medical University 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YU mei Wu, Doctor (86 13701016571, wym597118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The HR-HPV clearance (time frame: 24 months). 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 5 Jul 2018.