Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 180,000
- Locations
- 2
- Primary Endpoint
- Incidence of cervical cancer
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 23 Years to 29 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women ages 23-29 invited to screening.
Exclusion Criteria
- •Women who do not show up for screening or do not consent.
Arms & Interventions
HPV-based screening
Women 23-29 invited to cervical screening will have their samples analyzed for HPV.
Intervention: HPV testing (Diagnostic Test)
Outcomes
Primary Outcomes
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 10.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 1.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 2.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 3.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 4.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 5.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 6.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 7.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 8.
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Time Frame: Measured once during 1 year, year 9.
Cervical cancer incidence in the intervention group compared to a historical control group.
Secondary Outcomes
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 10.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 1.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 2.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 3.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 4.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 5.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 6.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 7.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 8.)
- Cost-effectiveness of the new screening method(Measured once during 1 year, year 9.)
Investigators
Joakim Dillner
Professor of Infectious Disease Epidemiology; Director of R&D
Karolinska Institutet