- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577925
The Standard Management of HPV Infection
The Standard Mangagement of High-Risk HPV Infection During Follow-up Visits
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: YU mei Wu, Doctor
- Phone Number: 86 13701016571
- Email: wym597118@163.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China
- Recruiting
- Yu mei Wu
-
Contact:
- Yu mei Wu, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- age above 70
- with severe desease that influence the follow-up
- received other treatment on cervical lesion
- data incompleted
- not meet the inclusive criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HSIL
the patients with HSIL
|
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.
|
stage IA1 cervical squamous cancer
the patients with stage IA1 cervical squamous cancer
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The HR-HPV clearance
Time Frame: 24 months
|
The difference of the HR-HPV clearance between HSIL and stage IA1 cervical squamous cancer
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yu mei Wu, Doctor, Beijing Obstetrics and Gynecology Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZYLX201705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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