An interventional study of Adding Human Papillomavirus testing to organised cervical screening in Cervical Cancer and Cervical Intraepithelial Neoplasia, sponsored by Skane University Hospital. Completed at 1 site in Sweden. Open to female participants aged 32 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-05-28.
Sponsored by Skane University Hospital · Not applicable, Interventional, and 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+).
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 12,527 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Skane University Hospital is the lead sponsor of 71 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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
This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.
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Skane University Hospital