Offering Cervical Cancer Screening to Older Women

Mass Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114968
• Other study ID #: 2702
• Status: Recruiting
• Start date: September 30, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2020
• Source: University of Aarhus
• Contact: Mette Tranberg, Post doc PhD
• Phone: +45 784 20264
• Email: mettrani[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 65 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Mass Screening
• Neoplasms
• Uterine Cervical Disease
• Uterine Cervical Diseases
• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms
• Uterine Neoplasm
• Uterine Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Mette Tranberg Nielsen	Randers	Randers NØ

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation rate in the intervention group:	Participation rate, eg the roportion of targeted women participating by GP-based screening or self-sampling	1 year post invitation
Primary	HPV prevalence	Number of women tested positive for HPV	1 year post invitation
Primary	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	90 days post test results
Primary	Screening history	Screening history of participants and non-participants in the intervention group	Average of 10 years
Primary	Intervention versus control group:	Participation rate	1 year post invitation
Primary	Cytological findings	Proportion of abnormal cytological findings between the intervention and control group is compared	1 year post invitation
Primary	Histological findings	Proportion of abnormal histological findings between the intervention and control group is compared	1 year post invitation
Primary	Incidence	The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group	5 year post invitation
Primary	Mortality	The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group	5 year post invitation