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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm|
- number of CIN 2+ cases for the two different diagnostic procedures [ Time Frame: first evaluation, the 1 of january 2013 ] [ Designated as safety issue: No ]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
- calculation of cost for the two different diagnostic procedures [ Time Frame: first evaluation, 1 of January 2013 ] [ Designated as safety issue: No ]The cost for the new procedure with HPV test in primary screening will be compared to the routine procedure with primary cytology
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: HPV testing
Women randomised to this arm get primary HPV testing
Other: HPV testing
Testing for Human Papilloma Virus
No Intervention: cytology
women included follow the standard procedure with primary cytology
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.
Cervical cancer screening at age 60:
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.
Cervical cancer screening at age 30-40:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511328
|Contact: Sven Törnberg, MD, PhD||46-8-51773194||Sven.email@example.com|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 141 86|
|Contact: Mikael Björnstedt, MD, PhD +46-8-58583809 Mikael.Bjornstedt@karolinska.se|
|Principal Investigator: Joakim Dillner, MD, PhD|
|Principal Investigator:||Joakim Dillner, MD, PhD||Karolinska Institutet|