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Clinical Trials/NCT01511328
NCT01511328
Active, not recruiting
Not Applicable

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

Karolinska Institutet1 site in 1 country270,000 target enrollmentJanuary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
High-grade Cervical Intraepithelial Neoplasia
Sponsor
Karolinska Institutet
Enrollment
270000
Locations
1
Primary Endpoint
Cervical intraepithelial neoplasia 2+ (CIN2+)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
December 2031
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joakim Dillner

MD, PhD

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Cost for the two different diagnostic procedures(first evaluation, 1 of January 2013)
  • Invasive cervical cancer(first evaluation, after 2nd round of screening, approximately 8 years after enrollment)

Study Sites (1)

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