Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm
NCT ID: NCT01511328
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
270000 participants
INTERVENTIONAL
2012-01-01
2031-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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HPV testing
Women randomised to this arm get primary HPV testing
HPV testing
Testing for Human Papilloma Virus
cytology
women included follow the standard procedure with primary cytology
No interventions assigned to this group
Interventions
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HPV testing
Testing for Human Papilloma Virus
Eligibility Criteria
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Inclusion Criteria
Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.
30 Years
64 Years
FEMALE
No
Sponsors
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Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Joakim Dillner
MD, PhD
Principal Investigators
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Joakim Dillner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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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.
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.
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.
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.
Yao Q, Wang J, Elfstrom KM, Strander B, Dillner J, Sundstrom K. Evaluation of primary HPV-based cervical screening among older women: Long-term follow-up of a randomized healthcare policy trial in Sweden. PLoS Med. 2024 Dec 19;21(12):e1004505. doi: 10.1371/journal.pmed.1004505. eCollection 2024 Dec.
Wang J, Elfstrom KM, Dillner J. Human papillomavirus-based cervical screening and long-term cervical cancer risk: a randomised health-care policy trial in Sweden. Lancet Public Health. 2024 Nov;9(11):e886-e895. doi: 10.1016/S2468-2667(24)00218-4.
Wang J, Elfstrom KM, Lagheden C, Eklund C, Sundstrom K, Sparen P, Dillner J. Impact of cervical screening by human papillomavirus genotype: Population-based estimations. PLoS Med. 2023 Oct 27;20(10):e1004304. doi: 10.1371/journal.pmed.1004304. eCollection 2023 Oct.
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.
Other Identifiers
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SLL-KI-HPV
Identifier Type: -
Identifier Source: org_study_id
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