HPV-based Screening Among Women 23-29 Years of Age
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age23-29
SponsorKarolinska Institutet
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Women ages 23-29 invited to screening.
Disqualifiers
Women who do not show up for screening or do not consent.
Trial design
Design model
Single group
Treatments tested in this trial
HPV testing
Diagnostic testAll 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.
Treatment groups
180,000 Participants
are divided into 1 treatment groupGroup A: HPV-based screeningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Time frame
Measured once during 1 year, year 1.2
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Time frame
Measured once during 1 year, year 2.3
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Time frame
Measured once during 1 year, year 3.4
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Time frame
Measured once during 1 year, year 4.Secondary outcomes
1
Cost-effectiveness of the new screening method
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.
Time frame
Measured once during 1 year, year 1.2
Cost-effectiveness of the new screening method
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.
Time frame
Measured once during 1 year, year 2.3
Cost-effectiveness of the new screening method
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.
Time frame
Measured once during 1 year, year 3.4
Cost-effectiveness of the new screening method
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.
Time frame
Measured once during 1 year, year 4.Sponsors and contacts
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Source ClinicalTrials.gov