Brief Title
Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm
Official Title
Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm
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.
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.
Study Type
Interventional
Primary Outcome
Cervical intraepithelial neoplasia 2+ (CIN2+)
Secondary Outcome
Cost for the two different diagnostic procedures
Condition
High-grade Cervical Intraepithelial Neoplasia
Intervention
HPV testing
Study Arms / Comparison Groups
HPV testing
Description: Women randomised to this arm get primary HPV testing
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
270000
Start Date
January 1, 2012
Completion Date
December 2031
Primary Completion Date
June 30, 2017
Eligibility Criteria
Inclusion Criteria:
Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No
exclusion criteria.
Gender
Female
Ages
30 Years - 64 Years
Accepts Healthy Volunteers
No
Contacts
Joakim Dillner, MD, PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT01511328
Organization ID
SLL-KI-HPV
Responsible Party
Principal Investigator
Study Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
Study Sponsor
Joakim Dillner, MD, PhD, Principal Investigator, Karolinska Institutet
Verification Date
February 2023