Karolinska University Hospital
Stockholm, 141 86, Sweden
NCT Number: NCT01511328
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.
This study is active but is not currently recruiting participants.
30 year–64 year
Female
Interventional
Not applicable
Stockholm, 141 86, Sweden
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.
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.
Testing for Human Papilloma Virus
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
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
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.
Karolinska Institutet
Other
Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm
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