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

NCT ID: NCT05229679

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2038-12-31

Brief Summary

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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

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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

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Human Papilloma Virus Cervical Intraepithelial Neoplasia Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HPV-based screening

Women 23-29 invited to cervical screening will have their samples analyzed for HPV.

Group Type EXPERIMENTAL

HPV testing

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Women ages 23-29 invited to screening.

Exclusion Criteria

* Women who do not show up for screening or do not consent.
Minimum Eligible Age

23 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Joakim Dillner

Professor of Infectious Disease Epidemiology; Director of R&D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joakim Dillner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital/Karolinska Institutet

Locations

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Region of Skåne

Lund, Skåne County, Sweden

Site Status ACTIVE_NOT_RECRUITING

Region Stockholm

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Joakim Dillner, MD, PhD

Role: CONTACT

+46 (0) 72-468 24 60

Miriam Elfström, PhD

Role: CONTACT

+46 (0) 70-381 62 77

Facility Contacts

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Joakim Dillner, MD, PhD

Role: primary

+46 (0) 72-468 24 60

Other Identifiers

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2020-00053

Identifier Type: -

Identifier Source: org_study_id

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