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

Not Applicable

Active, not recruiting

• Conditions: Invasive Cervical Cancer; High-grade Cervical Intraepithelial Neoplasia
• Interventions: Other: HPV testing

• Registration Number: NCT01511328
• Lead Sponsor: Karolinska Institutet

Brief 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.

Study Timeline

• Study First Submitted: 2011-12-20
• Study Start: 2012-01-01
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Primary Completion: 2017-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 270000

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV testing	HPV testing	Women randomised to this arm get primary HPV testing

Primary Outcome Measures

Name	Time	Method
Cervical intraepithelial neoplasia 2+ (CIN2+)	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 Outcome Measures

Name	Time	Method
Cost for the two different diagnostic procedures	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
Invasive cervical cancer	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.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden