RecruitingNot ApplicableNCT05229679

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

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


Sponsor

Karolinska Institutet

Enrollment

180,000 participants

Start Date

Nov 16, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 23 YearsMax Age: 29 Years

Inclusion Criteria1

  • Women ages 23-29 invited to screening.

Exclusion Criteria1

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

Interventions

DIAGNOSTIC_TESTHPV testing

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.


Locations(2)

Region of Skåne

Lund, Skåne County, Sweden

Region Stockholm

Stockholm, Sweden

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NCT05229679


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