Offering Cervical Cancer Screening to Older Women

November 5, 2020 updated by: University of Aarhus

Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling

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.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mette Tranberg, Post doc PhD
  • Phone Number: +45 784 20264
  • Email: mettrani@rm.dk

Study Locations

    • Randers NØ
      • Randers, Randers NØ, Denmark, 8930
        • Recruiting
        • Mette Tranberg Nielsen
        • Contact:
          • Mette tranberg Nielsen, phd
          • Phone Number: +45 40113676
          • Email: mettrani@rm.dk
        • Contact:
          • Berit Andersen, MD, PhD
          • Phone Number: +45 784 20171
          • Email: berand@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 69 years (OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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 Names:
  • Opportunistics GP-based screening
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation rate in the intervention group:
Time Frame: 1 year post invitation
Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling
1 year post invitation
HPV prevalence
Time Frame: 1 year post invitation
Number of women tested positive for HPV
1 year post invitation
Compliance to follow-up among HPV-positive self-samplers
Time Frame: 90 days post test results
The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral
90 days post test results
Screening history
Time Frame: Average of 10 years
Screening history of participants and non-participants in the intervention group
Average of 10 years
Intervention versus control group:
Time Frame: 1 year post invitation
Participation rate
1 year post invitation
Cytological findings
Time Frame: 1 year post invitation
Proportion of abnormal cytological findings between the intervention and control group is compared
1 year post invitation
Histological findings
Time Frame: 1 year post invitation
Proportion of abnormal histological findings between the intervention and control group is compared
1 year post invitation
Incidence
Time Frame: 5 year post invitation
The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group
5 year post invitation
Mortality
Time Frame: 5 year post invitation
The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group
5 year post invitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mette T Tranberg, post doc phd, Randers Regional Hospital, Central Denmark Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2019

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (ACTUAL)

October 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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