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OpenTrials
Active, Not Recruiting

NCT Number: NCT01511328

Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

HPV testing

Other

Testing for Human Papilloma Virus

Primary outcomes

  1. Cervical intraepithelial neoplasia 2+ (CIN2+)

    Time frame: first evaluation, the 1 of january 2013

    The number of women with CIN2+ detected by primary HPV testing will be compared with the number of women with CIN2+ detected by primary cytology

Secondary outcomes

  1. Cost for the two different diagnostic procedures

    Time frame: first evaluation, 1 of January 2013

    The cost for the new procedure with HPV test in primary screening will be compared to the routine procedure with primary cytology

  2. Invasive cervical cancer

    Time frame: first evaluation, after 2nd round of screening, approximately 8 years after enrollment

    The number of women with invasive cervical cancer detected in the two arms.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm

Important dates

Study start
2012
Primary completion
2017
Study completion
2031
First posted
Jan 18, 2012
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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