A Retrospective Epidemiological Study of Natural History of HPV Infections in Women Aged 18 Years and Above With Recurrent Conization Following a Primary Conization for High Grade Lesions/ Microinvasive Cervical Carcinomas, in Norway
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.
研究概览
简要总结
This is a register-based, epidemiological study of HPV type distribution in women aged 18 years and above with recurrent conization following a primary conization for high grade lesions/ microinvasive carcinomas. This study will involve data collection from different databases in the Cancer Registry of Norway.
详细描述
This protocol posting has been updated following Protocol Amendment 1 (02 April 2010). The sections impacted are: enrolment, outcome measures and eligibility criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All subjects must meet the following criteria at study entry:
- •Women aged 18 years and above at the time of the collection of the primary cone specimen;
- •Who have undergone for the first time a conization due to high grade lesions or microinvasive cervical carcinomas, histologically diagnosed in 2003, with possible extension backwards in time;
- •Availability of recurrent cone specimen with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer;
- •Availability in designated local laboratories of the primary and recurrent cone specimens;
- •The cone specimen was adequately preserved;
- •Written informed consent obtained from the subject. If the subject is deceased, the cone and biopsy specimens will be used according to prior approval from the Ethics Committee.
排除标准
- 未提供
结局指标
主要结局
HPV-types as single group considered as new infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.
时间窗: At the end of the study.
HPV-types as single group considered as persistent infections in recurrent conizations with high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.
时间窗: At the end of the study.
次要结局
- HPV-types as individual types or as different groups considered as new infections in recurrent conizations presenting high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.(At the end of the study.)
- HPV-types as individual types or as different groups considered as persistent infections in recurrent conizations presenting high grade lesions, microinvasive cervical carcinomas or ICC diagnosis.(At the end of the study.)