Offering Cervical Cancer Screening to Older Women

Recruiting

• Conditions: Uterine Neoplasm; Uterine Cervical Neoplasm; Mass Screening; Uterine Cervical Disease
• Interventions: Other: GP-based screening or HPV self-sampling

• Registration Number: NCT04114968
• Lead Sponsor: University of Aarhus

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-20
• Study Start: 2019-09-30
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention group	GP-based screening or HPV self-sampling	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.

Primary Outcome Measures

Name	Time	Method
Intervention versus control group:	1 year post invitation	Participation rate
Screening history	Average of 10 years	Screening history of participants and non-participants in the intervention group
Cytological findings	1 year post invitation	Proportion of abnormal cytological findings between the intervention and control group is compared
Incidence	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:	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	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	1 year post invitation	Proportion of abnormal histological findings between the intervention and control group is compared
HPV prevalence	1 year post invitation	Number of women tested positive for HPV
Mortality	5 year post invitation	The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group

Trial Locations

Locations (1)

Mette Tranberg Nielsen; 🇩🇰 Randers, Randers NØ, Denmark