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Offering Cervical Cancer Screening to Older Women

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ClinicalTrials.gov Identifier: NCT04114968
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment
Uterine Cervical Neoplasm Uterine Neoplasm Uterine Cervical Disease Mass Screening Other: GP-based screening or HPV self-sampling

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.

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reducing the Burden of Cervical Cancer Among Older Women by Expanding the Screening Age and Offering HPV Self-sampling
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.
Other: 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 Name: 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



Primary Outcome Measures :
  1. 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

  2. HPV prevalence [ Time Frame: 1 year post invitation ]
    Number of women tested positive for HPV

  3. 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

  4. Screening history [ Time Frame: Average of 10 years ]
    Screening history of participants and non-participants in the intervention group

  5. Intervention versus control group: [ Time Frame: 1 year post invitation ]
    Participation rate

  6. Cytological findings [ Time Frame: 1 year post invitation ]
    Proportion of abnormal cytological findings between the intervention and control group is compared

  7. Histological findings [ Time Frame: 1 year post invitation ]
    Proportion of abnormal histological findings between the intervention and control group is compared

  8. 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

  9. 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



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Ages Eligible for Study:   65 Years to 69 Years   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women are offered cervical cancer screening
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114968


Contacts
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Contact: Mette Tranberg, Post doc PhD +45 784 20264 mettrani@rm.dk

Locations
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Denmark
Mette Tranberg Nielsen Recruiting
Randers, Randers NØ, Denmark, 8930
Contact: Mette tranberg Nielsen, phd    40113676 ext +45    mettrani@rm.dk   
Contact: Berit Andersen, MD, PhD    784 20171 ext +45    berand@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Mette T Tranberg, post doc phd Randers Regional Hospital, Central Denmark Region

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04114968     History of Changes
Other Study ID Numbers: 2702
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
HPV self-sampling, cervical cancer screening in older women
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female