Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2019-09-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention group
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.
GP-based screening or HPV self-sampling
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.
Control group
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
No interventions assigned to this group
Interventions
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GP-based screening or HPV self-sampling
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
69 Years
FEMALE
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Mette T Tranberg, post doc phd
Role: PRINCIPAL_INVESTIGATOR
Randers Regional Hospital, Central Denmark Region
Locations
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Mette Tranberg Nielsen
Randers, Randers NØ, Denmark
Countries
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Central Contacts
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Facility Contacts
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Mette tranberg Nielsen, phd
Role: primary
Berit Andersen, MD, PhD
Role: backup
References
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Tranberg M, Petersen LK, Hammer A, Elfstrom M, Blaakaer J, Jorgensen SF, Bennetsen MH, Jensen JS, Andersen B. Value of a catch-up HPV test in women aged 65 and above: A Danish population-based nonrandomized intervention study. PLoS Med. 2023 Jul 6;20(7):e1004253. doi: 10.1371/journal.pmed.1004253. eCollection 2023 Jul.
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.
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.
Other Identifiers
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2702
Identifier Type: -
Identifier Source: org_study_id