跳至主要内容
临床试验/NCT03577925
NCT03577925Unknown不适用

The Standard Mangagement of High-Risk HPV Infection During Follow-up Visits

Capital Medical University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
1
主要终点
The HR-HPV clearance

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • age above 70
  • with severe desease that influence the follow-up
  • received other treatment on cervical lesion
  • data incompleted
  • not meet the inclusive criteria

结局指标

主要结局

The HR-HPV clearance

时间窗: 24 months

The difference of the HR-HPV clearance between HSIL and stage IA1 cervical squamous cancer

次要结局

未报告次要终点

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu mei Wu

Yu mei Wu

Capital Medical University

研究点 (1)

Loading locations...

相似试验