HPV-based Screening Among Women 23-29 Years of Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HPV testing.
- Who it may be relevant to
- Registry conditions: Human Papilloma Virus, Cervical Intraepithelial Neoplasia, Cervical Cancer. Basic parameters: 23 years — 29 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women
Overview
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.
Interventions
- 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 rega
Primary outcome measures
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 1.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 2.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 3.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 4.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 5.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 6.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 7.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 8.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 9.]
- Incidence of cervical cancer [Time frame: Measured once during 1 year, year 10.]
Secondary outcome measures (10)
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 1.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 2.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 3.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 4.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 5.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 6.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 7.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 8.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 9.]
- Cost-effectiveness of the new screening method [Time frame: Measured once during 1 year, year 10.]
Eligibility criteria
Inclusion criteria
- Women ages 23-29 invited to screening.
Exclusion criteria
- Women who do not show up for screening or do not consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Sweden · 2 centers
- Region of Skåne — Lund
- Region Stockholm — Stockholm
Identifiers
NCT: NCT05229679 · 2020-00053