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临床试验/NCT03873376
NCT03873376已完成不适用

A Pragmatic Randomized Controlled Trial of Self-sampling Among Long-term Non-attenders to Cervical Cancer Screening

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 5,669 人开始时间: 2019年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,669
试验地点
2
主要终点
Screening attendance rate (%)

研究概览

简要总结

The trial will evaluate whether human papillomavirus (HPV) self-sampling may increase cervical cancer screening attendance among under-screened women in Norway, how different ways of offering self-sampling and follow-up may affect attendance, and whether self-sampling may reduce inequities in attendance.

详细描述

A randomized control trial will be performed on the effect of vaginal HPV self-sampling on screening attendance, targeting women age 35-69 who have not attended screening for at least 10 years. The women will be randomly allocated to one of three interventions: (i) receive a reminder to be screened by a physician; (ii) receive a self-sampling kit; (iii) receive an offer to order a self-sampling kit. Comparisons of the screening attendance among the interventions will be made. To also address potential effects on inequities, the analyses will include comparisons by sociodemographic characteristics. The rates of cervical cancer/precancer among the interventions will also be compared. Further, to assess the feasibility of and the compliance to follow-up after a positive HPV test in this population, half of the HPV-positive women from each self-sampling arm will be referred to initial follow-up by their regular general practitioner (GP), while the other half will be referred to initial follow-up by a gynecologist. The project will be embedded in the national cervical cancer screening program, and will utilize the extensive nationwide registers describing performance and outcomes of screening collected by the Cancer Registry of Norway.

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
35 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women living in the regions Hordaland, Vest-Agder, Rogaland or Sør-Trøndelag, who have been eligible for screening in Norway, but who have not attended screening for at least 10 years (2009-2018)

排除标准

  • Women who have not been eligible for cervical cancer screening during the entire 10 year period (2009-2018)

结局指标

主要结局

Screening attendance rate (%)

时间窗: 6 months

The primary outcome measure is the attendance rate to cervical cancer screening. Attendance is defined as returning a self-sampling test, or being screened by a physician during the 6 months following receipt of the invitation letter

次要结局

  • Prevalence of CIN2+ (proportion of cervical intraepithelial neoplasia grade 2 or worse)(6 months)
  • Compliance to clinical follow-up of a high-risk HPV positive screening test (%)(6 months)
  • Prevalence of high-risk HPV (%)(6 months)

研究者

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

Bo Terning Hansen

Principal Investigator

Oslo University Hospital

研究点 (2)

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