Offering Cervical Cancer Screening to Older Women

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    20000
  • sponsor
    University of Aarhus
Updated on 27 January 2021

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.

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.

Details
Condition Cervical Cancer, Cervical Cancer, Screening, Disorders of cervix NOS, Disorder of uterus NOS, Uterine Disorders, Uterine Cancer, Uterine Cancer, Uterine Disorders, uterine neoplasm, cervical neoplasm, uterine cervix, cervical disease
Treatment GP-based screening or HPV self-sampling
Clinical Study IdentifierNCT04114968
SponsorUniversity of Aarhus
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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