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临床试验/NCT01511328
NCT01511328进行中(未招募)不适用

Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 270,000 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
270,000
试验地点
2
主要终点
Cervical intraepithelial neoplasia 2+ (CIN2+)

研究概览

简要总结

The purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.

详细描述

Primary HPV screening is a method with higher sensitivity than cytology for detection of high-grade cervical intraepithelial neoplasia, which is the precursor of cervical cancer. In particular, HPV test is a better test for revealing adenocarcinomas, since these cancers often show a normal cytology.

Cytology is less effective in older women, and screening with cytology in women over 60 has no documented effect. Today a large part of cervical cancer develop in women older than 60, to whom no screening is offered. The prevalence of HPV is around 4% in this age group. Since we know that testing negative for HPV gives a better long-term protection against cervical cancer compared to cytology, primary screening for HPV in 60-year old women would give a longer lasting protection in this high-risk group compared with today.

HPV screening is most cost effective above 35 years of age. The reason for this is that HPV is less prevalent at age 35 than in younger women and also because cervical cancer seldom develops before this age. Since the HPV test has a negative predictive value (NPV) of almost 100% this could lead to longer screening intervals, which would be improve cost-effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
30 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.

排除标准

  • 未提供

研究组 & 干预措施

cytology

No Intervention

women included follow the standard procedure with primary cytology

HPV testing

Experimental

Women randomised to this arm get primary HPV testing

干预措施: HPV testing (Other)

结局指标

主要结局

Cervical intraepithelial neoplasia 2+ (CIN2+)

时间窗: first evaluation, the 1 of january 2013

The number of women with CIN2+ detected by primary HPV testing will be compared with the number of women with CIN2+ detected by primary cytology

次要结局

  • Cost for the two different diagnostic procedures(first evaluation, 1 of January 2013)
  • Invasive cervical cancer(first evaluation, after 2nd round of screening, approximately 8 years after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joakim Dillner

MD, PhD

Karolinska Institutet

研究点 (2)

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