Cervical Cancer Clinical Trial
Official title:
Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening
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+).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Screening
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