Clinical trial NCT05229679: HPV-based Screening Among Women 23-29 Years of Age
Official title: Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Cervical Intraepithelial Neoplasia
Cervical Cancer
Keywords: Organized screening
HPV vaccination
Human papilloma virus
Prevention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 180000
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 1.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 2.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 3.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 4.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 5.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 6.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 7.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 8.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 9.
measure: Incidence of cervical cancer
timeFrame: Measured once during 1 year, year 10.
Secondary outcomes:
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 1.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 2.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 3.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 4.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 5.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 6.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 7.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 8.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 9.
measure: Cost-effectiveness of the new screening method
timeFrame: Measured once during 1 year, year 10.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Region of Skåne
state: Skåne
city: Stockholm
country: Sweden
facility: Region Stockholm
Study officials:
affiliation: Karolinska University Hospital/Karolinska Institutet
name: Joakim Dillner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: