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NCT Number: NCT05229679

HPV-based Screening Among Women 23-29 Years of Age

The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.

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Key information

Conditions

Human Papilloma Virus Cervical Cancer Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

23 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Region of Skåne, Lund, Skåne County, Sweden

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About this study

The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ages 23-29 invited to screening.

Exclusion criteria

  • Women who do not show up for screening or do not consent.

Treatment and study plan

HPV testing

Diagnostic Test

All women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method.

Primary outcomes

  1. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 1.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  2. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 2.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  3. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 3.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  4. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 4.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  5. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 5.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  6. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 6.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  7. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 7.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  8. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 8.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  9. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 9.

    Cervical cancer incidence in the intervention group compared to a historical control group.

  10. Incidence of cervical cancer

    Time frame: Measured once during 1 year, year 10.

    Cervical cancer incidence in the intervention group compared to a historical control group.

Secondary outcomes

  1. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 1.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  2. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 2.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  3. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 3.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  4. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 4.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  5. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 5.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  6. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 6.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  7. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 7.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  8. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 8.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  9. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 9.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

  10. Cost-effectiveness of the new screening method

    Time frame: Measured once during 1 year, year 10.

    Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.

Study contacts

Contact information is provided by the study sponsor or research team.

Joakim Dillner, MD, PhD

CONTACT

[email protected]

+46 (0) 72-468 24 60

Miriam Elfström, PhD

CONTACT

[email protected]

+46 (0) 70-381 62 77

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women

Important dates

Study start
2020
Primary completion
2038
Study completion
2038
First posted
Feb 8, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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