An observational study in Uterine Cervical Neoplasm, Uterine Neoplasm and Uterine Cervical Disease, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to female participants aged 65 Years to 69 Years. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by University of Aarhus · Observational
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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The study population will include women who had their last cervical cytology sample or screening invitation recorded 5 years or more ago
Exclusion Criteria:
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.
Other: GP-based screening or HPV self-sampling
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
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.
Also known as: Opportunistics GP-based screening
Participation rate in the intervention group:
Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling
Time frame: 1 year post invitation
HPV prevalence
Number of women tested positive for HPV
Time frame: 1 year post invitation
Compliance to follow-up among HPV-positive self-samplers
The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral
Time frame: 90 days post test results
Screening history
Screening history of participants and non-participants in the intervention group
Time frame: Average of 10 years
Intervention versus control group:
Participation rate
Time frame: 1 year post invitation
Cytological findings
Proportion of abnormal cytological findings between the intervention and control group is compared
Time frame: 1 year post invitation
Histological findings
Proportion of abnormal histological findings between the intervention and control group is compared
Time frame: 1 year post invitation
Incidence
The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group
Time frame: 5 year post invitation
Mortality
The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group
Time frame: 5 year post invitation
Plan to share: Undecided
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University of Aarhus