Offering Cervical Cancer Screening to Older Women

NCT04114968 | Unknown

• 1 other identifier: 2702
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasm; Uterine Neoplasm; Uterine Cervical Disease; Mass Screening

Keywords

HPV self-sampling, cervical cancer screening in older women

Outcome Measures

Primary Outcomes (9)

• 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

• HPV prevalence

  Number of women tested positive for HPV

  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

  90 days post test results

• Screening history

  Screening history of participants and non-participants in the intervention group

  Average of 10 years

• Intervention versus control group:

  Participation rate

  1 year post invitation

• Cytological findings

  Proportion of abnormal cytological findings between the intervention and control group is compared

  1 year post invitation

• Histological findings

  Proportion of abnormal histological findings between the intervention and control group is compared

  1 year post invitation

• Incidence

  The incidence rate of cervical cancer developed within 5 year is compared between the intervention and control group

  5 year post invitation

• Mortality

  The mortality rate of cervical cancer developed within 5 year is compared between the intervention and control group

  5 year post invitation

Study Arms (2)

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

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

Interventions

GP-based screening or HPV self-sampling OTHER

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.

Also known as: Opportunistics GP-based screening

Intervention group

Eligibility Criteria

• Age: 65 Years - 69 Years
• Gender Eligibility Details: Only women are offered cervical cancer screening
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Mette Tranberg Nielsen

Randers, Randers NØ, 8930, Denmark

RECRUITING

Related Publications (3)

• 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.

  PMID: 37410699 DERIVED

• 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.

  PMID: 33154056 DERIVED

• 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.

  PMID: 32894896 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Uterine Cervical Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mette T Tranberg, post doc phd

  Randers Regional Hospital, Central Denmark Region

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Tranberg, Post doc PhD

CONTACT

+45 784 20264; mettrani@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 3, 2019
• Study Start: September 30, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

DK (1)