- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04114968
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
Status
Recruiting
Intervention / Treatment
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
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Randers NØ
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Randers, Randers NØ, Denmark, 8930
- Recruiting
- Mette Tranberg Nielsen
-
Contact:
- Mette tranberg Nielsen, phd
- Phone Number: +45 40113676
- Email: mettrani@rm.dk
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Contact:
- Berit Andersen, MD, PhD
- Phone Number: +45 784 20171
- Email: berand@rm.dk
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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:
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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
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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
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The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral
|
90 days post test results
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Screening history
Time Frame: Average of 10 years
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Screening history of participants and non-participants in the intervention group
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Average of 10 years
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Intervention versus control group:
Time Frame: 1 year post invitation
|
Participation rate
|
1 year post invitation
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Cytological findings
Time Frame: 1 year post invitation
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Proportion of abnormal cytological findings between the intervention and control group is compared
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1 year post invitation
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Histological findings
Time Frame: 1 year post invitation
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Proportion of abnormal histological findings between the intervention and control group is compared
|
1 year post invitation
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Incidence
Time Frame: 5 year post invitation
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The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group
|
5 year post invitation
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Mortality
Time Frame: 5 year post invitation
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The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group
|
5 year post invitation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2702
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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