This trial is active, not recruiting.

Condition high-grade cervical intraepithelial neoplasia
Treatment hpv testing
Sponsor Karolinska Institutet
Collaborator Stockholm County Council, Sweden
Start date January 2012
End date December 2016
Trial size 270000 participants
Trial identifier NCT01511328, SLL-KI-HPV


The purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Women randomised to this arm get primary HPV testing
hpv testing
Testing for Human Papilloma Virus
(No Intervention)
women included follow the standard procedure with primary cytology

Primary Outcomes

number of CIN 2+ cases for the two different diagnostic procedures
time frame: first evaluation, the 1 of january 2013

Secondary Outcomes

calculation of cost for the two different diagnostic procedures
time frame: first evaluation, 1 of January 2013

Eligibility Criteria

Female participants from 30 years up to 64 years old.

Inclusion Criteria: Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.

Additional Information

Official title Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm
Principal investigator Joakim Dillner, MD, PhD
Description Primary HPV screening is a method with higher sensitivity than cytology for detection of high-grade cervical intraepithelial neoplasia, which is the precursor of cervical cancer. In particular, HPV test is a better test for revealing adenocarcinomas, since these cancers often show a normal cytology. Cervical cancer screening at age 60: Cytology is less effective in older women, and screening with cytology in women over 60 has no documented effect. Today a large part of cervical cancer develop in women older than 60, to whom no screening is offered. The prevalence of HPV is around 4% in this age group. Since we know that testing negative for HPV gives a better long-term protection against cervical cancer compared to cytology, primary screening for HPV in 60-year old women would give a longer lasting protection in this high-risk group compared with today. Cervical cancer screening at age 30-40: HPV screening is most cost effective above 35 years of age. The reason for this is that HPV is less prevalent at age 35 than in younger women and also because cervical cancer seldom develops before this age. Since the HPV test has a negative predictive value (NPV) of almost 100% this could lead to longer screening intervals, which would be improve cost-effectiveness.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.