Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Intervention versus control group:
研究概览
简要总结
This study evaluates the effect and feasibility of expanding the target population in the Danish cervical cancer screening program to include women aged 65 to 69 years. The study also evaluates if HPV self-sampling constitutes an appropriate screening method among older women.
详细描述
The study is a nationwide population-based prospective cohort study embedded in the routine cervical cancer screening program in the Central Denmark Region. The study includes all 65 to 69 years old Danish women with no record of a cervical cytology sample or screening invitation within the last five years. Furthermore, the women are not registered as ineligible for screening, eg due hysterectomy. Eligible women residing in the Central Denmark Region are allocated to the intervention group (n=20,000), while women residing in the other four Danish regions are allocated to the control group receiving standard care (n=71,500), which for this group is low-level opportunistic screening at the general practitioner (GP). The intervention group are invited for HPV-based screening by the GP or to request a self-sampling kit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 69 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •65 to 69 years;
- •Resident in Denmark
- •No record of a cervical cytology or screening invitation in the past 5 years
- •Not registered as ineligible for screening
排除标准
- •Migration to or from Denmark
- •Moving to or from the CDR
- •Residing in the CDR, but having GP in another region
- •A record of hysterectomy
结局指标
主要结局
Intervention versus control group:
时间窗: 1 year post invitation
Participation rate
Screening history
时间窗: Average of 10 years
Screening history of participants and non-participants in the intervention group
Cytological findings
时间窗: 1 year post invitation
Proportion of abnormal cytological findings between the intervention and control group is compared
Incidence
时间窗: 5 year post invitation
The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group
Participation rate in the intervention group:
时间窗: 1 year post invitation
Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling
Compliance to follow-up among HPV-positive self-samplers
时间窗: 90 days post test results
The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral
Histological findings
时间窗: 1 year post invitation
Proportion of abnormal histological findings between the intervention and control group is compared
HPV prevalence
时间窗: 1 year post invitation
Number of women tested positive for HPV
Mortality
时间窗: 5 year post invitation
The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group
次要结局
未报告次要终点