Clinical trial NCT03577925: The Standard Management of HPV Infection
Official title: The Standard Mangagement of High-Risk HPV Infection During Follow-up Visits
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the High-Risk HPV Infection
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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

Eligibility criteria: 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

Primary outcomes:
measure: The HR-HPV clearance
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yu mei Wu
state: Beijing
Study officials:
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Yu mei Wu, Doctor
role: STUDY_DIRECTOR
References: