Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening
NCT ID: NCT00479375
Last Updated: 2007-05-28
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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COMPLETED
NA
12527 participants
INTERVENTIONAL
1997-05-31
2007-05-31
Brief Summary
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Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Interventions
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Adding Human Papillomavirus testing to organised cervical screening
Eligibility Criteria
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Inclusion Criteria
* Attending the Swedish population-based organised cervical screening program
Exclusion Criteria
32 Years
38 Years
FEMALE
Yes
Sponsors
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Swedish Cancer Society
OTHER
Europe Against Cancer (European Union Directorate General XII- Public Health)
UNKNOWN
Skane University Hospital
OTHER
Principal Investigators
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Joakim Dillner, MD
Role: PRINCIPAL_INVESTIGATOR
Malmo University Hospital, Lund University
Locations
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Malmo University Hospital
Malmo, , Sweden
Countries
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References
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Forslund O, Antonsson A, Edlund K, van den Brule AJ, Hansson BG, Meijer CJ, Ryd W, Rylander E, Strand A, Wadell G, Dillner J, Johansson B. Population-based type-specific prevalence of high-risk human papillomavirus infection in middle-aged Swedish women. J Med Virol. 2002 Apr;66(4):535-41. doi: 10.1002/jmv.2178.
Elfgren K, Rylander E, Radberg T, Strander B, Strand A, Paajanen K, Sjoberg I, Ryd W, Silins I, Dillner J; Swedescreen Study Group. Colposcopic and histopathologic evaluation of women participating in population-based screening for human papillomavirus deoxyribonucleic acid persistence. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):650-7. doi: 10.1016/j.ajog.2005.01.056.
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.
Elfstrom KM, Smelov V, Johansson AL, Eklund C, Naucler P, Arnheim-Dahlstrom L, Dillner J. Long term duration of protective effect for HPV negative women: follow-up of primary HPV screening randomised controlled trial. BMJ. 2014 Jan 16;348:g130. doi: 10.1136/bmj.g130.
Naucler P, Ryd W, Tornberg S, Strand A, Wadell G, Elfgren K, Radberg T, Strander B, Johansson B, Forslund O, Hansson BG, Rylander E, Dillner J. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N Engl J Med. 2007 Oct 18;357(16):1589-97. doi: 10.1056/NEJMoa073204.
Other Identifiers
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3824-B00-05XAC
Identifier Type: -
Identifier Source: org_study_id