NCT05229679

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180,000 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 23 Years – 29 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Human Papilloma Virus
• Cervical Intraepithelial Neoplasia
• Cervical Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HPV 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.

Timeline

• Start date: 2020-11-16
• Primary completion: 2038-12-31
• Completion: 2038-12-31
• First posted: 2022-02-08
• Last updated: 2025-03-19

Locations

2 sites across 1 country: Sweden