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Clinical Trials/NCT05229679
NCT05229679
Recruiting
Not Applicable

Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women

Karolinska Institutet2 sites in 1 country180,000 target enrollmentNovember 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Papilloma Virus
Sponsor
Karolinska Institutet
Enrollment
180000
Locations
2
Primary Endpoint
Incidence of cervical cancer
Status
Recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2020
End Date
December 31, 2038
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joakim Dillner

Professor of Infectious Disease Epidemiology; Director of R&D

Karolinska Institutet

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.

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.

Secondary Outcomes

  • Cost-effectiveness of the new screening method(Measured once during 1 year, year 10.)

Study Sites (2)

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