Offering Cervical Cancer Screening to Older Women

University of Aarhus

Status: Enrolling

Conditions: Uterine Cervical Neoplasm; Uterine Neoplasm; Uterine Cervical Disease; Mass Screening

Treatments: Other: GP-based screening or HPV self-sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04114968

2702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: Female

Ages: 65 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Death
• 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

Trial design

20,000 participants in 2 patient groups

Intervention group

Description:

Eligible women residing in the Central Denmark Region will be assigned to intervention group. Women in the intervention group receive an invitation for HPV-based cervical cancer screening by attending either 1) GP-based screening or 2) HPV self-sampling. The self-sampling kit includes the dry Evalyn brush self-sampling device (Rovers Medical Devices B.V, Oss, Netherlands), written and picture-based user instructions on how to collect and mail the self-sample, and a prestamped return envelope addressed to the Department of Pathology, Randers Regional Hospital.

Treatment:

Other: GP-based screening or HPV self-sampling

Control group

Description:

Eligible women residing in the other five Danish regions (North, Central, South, Zealand and Capital ) will be assigned to control group. Women in the control group will receive usual care, which for 65-69 year-old women is opportunistic cervical cancer screening at the GP