Clinical trial NCT04114968: Offering Cervical Cancer Screening to Older Women
Official title: Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Cervical Neoplasm
Uterine Neoplasm
Uterine Cervical Disease
Mass Screening
Keywords: HPV self-sampling, cervical cancer screening in older women
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 69
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include women who had their last cervical cytology sample or screening invitation recorded 5 years or more ago

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation rate in the intervention group:
timeFrame: 1 year post invitation
measure: HPV prevalence
timeFrame: 1 year post invitation
measure: Compliance to follow-up among HPV-positive self-samplers
timeFrame: 90 days post test results
measure: Screening history
timeFrame: Average of 10 years
measure: Intervention versus control group:
timeFrame: 1 year post invitation
measure: Cytological findings
timeFrame: 1 year post invitation
measure: Histological findings
timeFrame: 1 year post invitation
measure: Incidence
timeFrame: 5 year post invitation
measure: Mortality
timeFrame: 5 year post invitation
Secondary outcomes:
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Mette Tranberg Nielsen
state: Randers NØ
Study officials:
affiliation: Randers Regional Hospital, Central Denmark Region
name: Mette T Tranberg, post doc phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tranberg M, Petersen LK, Elfstrom KM, Hammer A, Blaakaer J, Bennetsen MH, Jensen JS, Andersen B. Expanding the upper age limit for cervical cancer screening: a protocol for a nationwide non-randomised intervention study. BMJ Open. 2020 Nov 5;10(11):e039636. doi: 10.1136/bmjopen-2020-039636.
citation: Hammer A, Gustafson LW, Christensen PN, Brondum R, Andersen B, Andersen RH, Tranberg M. Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience. Cancer Med. 2020 Nov;9(21):8235-8242. doi: 10.1002/cam4.3399. Epub 2020 Sep 7.