Clinical trial · Observational
Offering Cervical Cancer Screening to Older Women
Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling
NCT04114968CI-TRIAL-00048161unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mass Screening | — | UNRESOLVED | — |
| Uterine Cervical Disease | — | UNRESOLVED | — |
| Uterine Cervical Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
| Uterine Neoplasm | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GP-based screening or HPV self-sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Intervention group
- description
- 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.
- interventionNames
- Other: GP-based screening or HPV self-sampling
- label
- Control group
- description
- 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
Primary outcomes (9)
- measure
- Participation rate in the intervention group:
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDTranberg 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. PMID 37410699
- DERIVEDTranberg 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. PMID 33154056
- DERIVEDHammer 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. PMID 32894896