Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

Overview

Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect. 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+).

Full Title of Study: “Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Double

Interventions

  • Procedure: Adding Human Papillomavirus testing to organised cervical screening

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of CIN2/CIN3+ lesions (which includes invasive cancers and in situ adenocarcinomas) found by subsequent screening (i.e. after the enrollment screening round and its associated follow-up).
    • Time Frame: On average 4 years post baseline

Secondary Measures

  • Secondary outcomes were the incidence of CIN2/CIN3+ lesions at enrollment screening (including associated follow-up) and outcomes stratified by CIN2 and CIN3+ lesions as endpoints.
    • Time Frame: On average 4 years post baseline
  • Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds
    • Time Frame: On average 7, 10, 13 (et cetera) years post base-line

Participating in This Clinical Trial

Inclusion Criteria

  • Women aged 32-38 years old – Attending the Swedish population-based organised cervical screening program Exclusion Criteria:

  • Not providing informed consent

Gender Eligibility: Female

Minimum Age: 32 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Skane University Hospital
  • Collaborator
    • Swedish Cancer Society
  • Overall Official(s)
    • Joakim Dillner, MD, Principal Investigator, Malmo University Hospital, Lund University

References

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. Erratum In: J Med Virol 2002 Jul;67(3):467.

Citations Reporting on Results

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.

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