Clinical trial NCT01511328: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: High-grade Cervical Intraepithelial Neoplasia
Invasive Cervical Cancer
Keywords: HPV testing
Primary screening
Cervical Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-01-18
Enrollment: 270000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Cervical intraepithelial neoplasia 2+ (CIN2+)
timeFrame: first evaluation, the 1 of january 2013
Secondary outcomes:
measure: Cost for the two different diagnostic procedures
timeFrame: first evaluation, 1 of January 2013
measure: Invasive cervical cancer
timeFrame: first evaluation, after 2nd round of screening, approximately 8 years after enrollment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Joakim Dillner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arbyn M, Ronco G, Meijer CJ, Naucler P. Trials comparing cytology with human papillomavirus screening. Lancet Oncol. 2009 Oct;10(10):935-6. doi: 10.1016/S1470-2045(09)70296-7. No abstract available.
citation: Naucler P, Ryd W, Tornberg S, Strand A, Wadell G, Elfgren K, Radberg T, Strander B, Forslund O, Hansson BG, Hagmar B, Johansson B, Rylander E, Dillner J. Efficacy of HPV DNA testing with cytology triage and/or repeat HPV DNA testing in primary cervical cancer screening. J Natl Cancer Inst. 2009 Jan 21;101(2):88-99. doi: 10.1093/jnci/djn444. Epub 2009 Jan 13.
citation: Lamin H, Eklund C, Elfstrom KM, Carlsten-Thor A, Hortlund M, Elfgren K, Tornberg S, Dillner J. Randomised healthcare policy evaluation of organised primary human papillomavirus screening of women aged 56-60. BMJ Open. 2017 May 30;7(5):e014788. doi: 10.1136/bmjopen-2016-014788.
citation: Elfstrom KM, Eklund C, Lamin H, Ohman D, Hortlund M, Elfgren K, Sundstrom K, Dillner J. Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial. PLoS Med. 2021 Aug 23;18(8):e1003748. doi: 10.1371/journal.pmed.1003748. eCollection 2021 Aug.
citation: Sahlgren H, Elfstrom KM, Lamin H, Carlsten-Thor A, Eklund C, Dillner J, Elfgren K. Colposcopic and histopathologic evaluation of women with HPV persistence exiting an organized screening program. Am J Obstet Gynecol. 2020 Mar;222(3):253.e1-253.e8. doi: 10.1016/j.ajog.2019.09.039. Epub 2019 Oct 1.