NCT04114968

Offering Cervical Cancer Screening to Older Women

Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 65 Years – 69 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Uterine Cervical Neoplasm
• Uterine Neoplasm
• Uterine Cervical Disease
• Mass Screening

Interventions

Type	Name	Description
OTHER	GP-based screening or HPV self-sampling	Women in the intervention group will receive an invitation for HPV-based cervical cancer screening by either 1) scheduling an appointment for a cervical cytology by the GP or 2) collect a cervico-vaginal sample themselves in their own home using a self-sampling kit.

Timeline

• Start date: 2019-09-30
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2019-10-03
• Last updated: 2020-11-06

Locations

1 site across 1 country: Denmark