NCT01511328

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270,000 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 30 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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. 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.

Conditions

• High-grade Cervical Intraepithelial Neoplasia
• Invasive Cervical Cancer

Interventions

Type	Name	Description
OTHER	HPV testing	Testing for Human Papilloma Virus

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-06-30
• Completion: 2031-12-01
• First posted: 2012-01-18
• Last updated: 2024-05-16

Locations

1 site across 1 country: Sweden