The Standard Management of HPV Infection

NCT ID: NCT03577925

Last Updated: 2018-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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

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the High-Risk HPV Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HSIL

the patients with HSIL

HPV genotype test

Intervention Type DIAGNOSTIC_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.

stage IA1 cervical squamous cancer

the patients with stage IA1 cervical squamous cancer

HPV genotype test

Intervention Type DIAGNOSTIC_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.

Interventions

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HPV genotype 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yu mei Wu

Yu mei Wu

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu mei Wu, Doctor

Role: STUDY_DIRECTOR

Beijing Obstetrics and Gynecology Hospital

Locations

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Yu mei Wu

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YU mei Wu, Doctor

Role: CONTACT

86 13701016571

Facility Contacts

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Yu mei Wu, Doctor

Role: primary

Other Identifiers

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ZYLX201705

Identifier Type: -

Identifier Source: org_study_id

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