Uterine Cervical NeoplasmNCT04114968
Offering Cervical Cancer Screening to Older Women
An observational study of Uterine Cervical Neoplasm and Uterine Neoplasm, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 69 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasm, Uterine Neoplasm, Uterine Cervical Disease
- What is being tested?
- GP-based screening or HPV self-sampling
- How many people
- 20,000 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Sep 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 69 years
- Women only
- Older adult
Study population: The study population will include women who had their last cervical cytology sample or screening invitation recorded 5 years or more ago
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Mette Tranberg Nielsen
Randers, Randers NØ, 8930
Mette tranberg Nielsen, phd, 40113676 ext. +45, mettrani@rm.dk
Berit Andersen, MD, PhD, 784 20171 ext. +45, berand@rm.dk
About this study
Official title: 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.
Read the 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.
- Being tested
- GP-based screening or HPV self-sampling
- Keywords
- HPV self-sampling, cervical cancer screening in older women
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP-based screening or HPV self-samplingOther
Also called Opportunistics GP-based screening
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: GP-based screening or HPV self-sampling | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Participation rate in the intervention group:
Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling
Measured: 1 year post invitation
HPV prevalence
Number of women tested positive for HPV
Measured: 1 year post invitation
Compliance to follow-up among HPV-positive self-samplers
The proportion of HPV-positive self-samplers who attend appropriate follow-up by their GP for onward referral
Measured: 90 days post test results
Screening history
Screening history of participants and non-participants in the intervention group
Measured: Average of 10 years
Intervention versus control group:
Participation rate
Measured: 1 year post invitation
Cytological findings
Proportion of abnormal cytological findings between the intervention and control group is compared
Measured: 1 year post invitation
Histological findings
Proportion of abnormal histological findings between the intervention and control group is compared
Measured: 1 year post invitation
Incidence
The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group
Measured: 5 year post invitation
Mortality
The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group
Measured: 5 year post invitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start30 Sep 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette T Tranberg, post doc phd, Principal investigator, Randers Regional Hospital, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114968
- Sponsor's protocol ID
- 2702
- Status last verified
- Nov 2020
- First submitted
- 20 Sep 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37410699Tranberg 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.
PubMed 33154056Hammer 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.
PubMed 32894896
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling
- ClinicalTrials.gov ID
- NCT04114968
- Acronym / sponsor ID
- 2702
- Keywords
- HPV self-sampling, cervical cancer screening in older women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: GP-based screening or HPV self-samplingEligible 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. |
| 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 |
Who may qualify
- Ages
- 65 to 69 years
- Sex
- Female only
- Age groups
- Older adult
- Study population
- The study population will include women who had their last cervical cytology sample or screening invitation recorded 5 years or more ago
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP-based screening or HPV self-samplingAlso: Opportunistics GP-based screeningWomen 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 group |
Primary outcome
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
HPV prevalence
Time frame: 1 year post invitation
Number of women tested positive for HPV
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
Screening history
Time frame: Average of 10 years
Screening history of participants and non-participants in the intervention group
Intervention versus control group:
Time frame: 1 year post invitation
Participation rate
Cytological findings
Time frame: 1 year post invitation
Proportion of abnormal cytological findings between the intervention and control group is compared
Histological findings
Time frame: 1 year post invitation
Proportion of abnormal histological findings between the intervention and control group is compared
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Derived from this study: PubMed 37410699Tranberg 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.
- Derived from this study: PubMed 33154056Tranberg 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.
- Derived from this study: PubMed 32894896Hammer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette T Tranberg, post doc phd principal investigator
Randers Regional Hospital, Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasm and Uterine Neoplasm, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mette Tranberg, Post doc PhD (+45 784 20264, mettrani@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate in the intervention group: (time frame: 1 year post invitation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114968, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.